Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02970942
• Collaborator: (none)
• Enrollment: 320
• Locations: 158
• Arms: 6
• Actual Duration (Months): 39.6
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

Condition or Disease	Intervention/Treatment	Phase
Hepatobiliary Disorders; Non-alcoholic Steatohepatitis	Drug: Semaglutide; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
• Actual Study Start Date: Nov 30, 2016
• Actual Primary Completion Date: Feb 13, 2020
• Actual Study Completion Date: Mar 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 0,1 mg	Drug: Semaglutide; Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Experimental: Semaglutide 0,2 mg	Drug: Semaglutide; Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Experimental: Semaglutide 0,4 mg	Drug: Semaglutide; Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Placebo Comparator: Placebo 1	Drug: Placebo; Once daily administration subcutaneously ( s.c., under the skin)
Placebo Comparator: Placebo 2	Drug: Placebo; Once daily administration subcutaneously ( s.c., under the skin)
Placebo Comparator: Placebo 3	Drug: Placebo; Once daily administration subcutaneously ( s.c., under the skin)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) [After 72 weeks]

   NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Secondary Outcome Measures

1. Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No) [After 72 weeks]

   NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.

2. Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS) [Baseline (week 0), Week 72]

   Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

3. Percentage of Participants With Change in Steatosis [Baseline (week 0), Week 72]

   Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

4. Percentage of Participants With Change in Lobular Inflammation [Baseline (week 0), Week 72]

   Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

5. Percentage of Participants With Change in Hepatocyte Ballooning [Baseline (week 0), Week 72]

   Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

6. Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification [Baseline (week 0), Week 72]

   Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

7. Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score [Baseline (week 0), Week 72]

   Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

8. Change in Fibrosis-4 Score [Baseline (week 0), Week 72]

   Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

9. Change in NAFLD Fibrosis Score (NFS) [Baseline (week 0), Week 72]

   Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

10. Change in Alanine Aminotransferase (ALT) [Baseline (week 0), Week 72]

    Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

11. Change in Aspartate Aminotransferase (AST) [Baseline (week 0), Week 72]

    Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

12. Change in Gamma Glutamyl Transferase (GGT) [Baseline (week 0), Week 72]

    Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

13. Change in Albumin [Baseline (week 0), Week 72]

    Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

14. Change in International Normalized Ratio (INR) [Baseline (week 0), Week 72]

    Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

15. Change in Enhanced Liver Fibrosis (ELF) [Baseline (week 0), Week 72]

    Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) ≥ 7.7 - < 9.8: Moderate fibrosis; c) ≥ 9.8 - < 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

16. Change in Cytokeratin 18 (CK-18) Fragments [Baseline (week 0), Week 72]

    Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

17. Change in microRNA 122 (miR-122) [Baseline (week 0), Week 72]

    Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

18. Change in Interleukin-1 Receptor (IL-1R) Antagonist [Baseline (week 0), Week 72]

    Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

19. Change in Monocyte Chemoattractant Protein 1 (MCP-1) [Baseline (week 0), Week 72]

    Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

20. Change in Fibroblast Growth Factor 21 (FGF-21) [Baseline (week 0), Week 72]

    Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

21. Change in Liver Stiffness Assessed by FibroScan® [Baseline (week 0), Week 72]

    Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

22. Change in Liver Steatosis Assessed by FibroScan® [Baseline (week 0), Week 72]

    Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

23. Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No) [Week 72]

    Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

24. Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No) [Week 72]

    Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

25. Change in Body Weight [Baseline (week 0), Week 72]

    Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

26. Change in Waist Circumference [Baseline (week 0), Week 72]

    Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

27. Change in Body Mass Index (BMI) [Baseline (week 0), Week 72]

    Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

28. Change in Glycosylated Haemoglobin (HbA1c) (%-Point) [Baseline (week 0), Week 72]

    Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

29. Change in HbA1c (Millimoles Per Mole) [Baseline (week 0), Week 72]

    Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

30. Change in Fasting Plasma Glucose (FPG) [Baseline (week 0), Week 72]

    Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

31. Change in Fasting Glucagon [Baseline (week 0), Week 72]

    Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

32. Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR) [Baseline (week 0), Week 72]

    Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

33. Change in Diastolic Blood Pressure (DBP) [Baseline (week 0), Week 72]

    Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

34. Change in Systolic Blood Pressure (SBP) [Baseline (week 0), Week 72]

    Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

35. Change in Total Cholesterol [Baseline (week 0), Week 72]

    Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

36. Change in Low Density Lipoprotein (LDL) Cholesterol [Baseline (week 0), Week 72]

    Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

37. Change in High Density Lipoprotein (HDL) Cholesterol [Baseline (week 0), Week 72]

    Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

38. Change in Very Low Density Lipoprotein (VLDL) Cholesterol [Baseline (week 0), Week 72]

    Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

39. Change in Triglycerides [Baseline (week 0), Week 72]

    Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

40. Change in Free Fatty Acids [Baseline (week 0), Week 72]

    Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

41. Change in High Sensitivity C-reactive Protein (hsCRP) [Baseline (week 0), Week 72]

    Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

42. Change in Short Form 36 (SF-36) Score [Baseline (week 0), Week 72]

    Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

43. Number of Treatment-emergent Adverse Events (TEAEs) [From week 0 to week 79]

    An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.

44. Number of Treatment-emergent Hypoglycaemic Episodes [From week 0 to week 79]

    Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

45. Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes [From week 0 to week 79]

    Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.

46. Number of Treatment-emergent Severe Hypoglycaemic Episodes [From week 0 to week 79]

    Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

47. Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events [From week 0 to week 79]

    Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

48. Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No) [From week 0 to week 79]

    Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

49. Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No) [From week 0 to week 79]

    Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

50. Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No) [From week 0 to week 79]

    Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

51. Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No) [From week 0 to week 79]

    Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

52. Change in Pulse From Baseline to Week 72 [Baseline (week 0), Week 72]

    Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

53. Percentage of Participants With Change in Electrocardiogram (ECG) [Baseline (week 0), Week 72]

    A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

54. Percentage of Participants With Change in Physical Examination: Cardiovascular System [Week -6, week 72]

    Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

55. Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System [Week -6, week 72]

    Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

56. Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth [Week -6, week 72]

    Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

57. Percentage of Participants With Change in Physical Examination: General Appearance [Week -6, week 72]

    Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

58. Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck [Week -6, week 72]

    Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

59. Percentage of Participants With Change in Physical Examination: Lymph Node Palpation [Week -6, week 72]

    Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

60. Percentage of Participants With Change in Physical Examination: Musculoskeletal System [Week -6, week 72]

    Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

61. Percentage of Participants With Change in Physical Examination: Respiratory System [Week -6, week 72]

    Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

62. Percentage of Participants With Change in Physical Examination: Skin [Week -6, week 72]

    Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

63. Percentage of Participants With Change in Physical Examination: Thyroid Gland [Week -6, week 72]

    Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

64. Change in Haematocrit [Baseline (week 0), Week 72]

    Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

65. Change in Haemoglobin (g/dL) [Baseline (week 0), Week 72]

    Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

66. Change in Haemoglobin (mmol/L) [Baseline (week 0), Week 72]

    Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

67. Change in Leukocytes [Baseline (week 0), Week 72]

    Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

68. Change in Thrombocytes [Baseline (week 0), Week 72]

    Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

69. Change in Erythrocytes [Baseline (week 0), Week 72]

    Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

70. Change in Creatinine (mg/dL) [Baseline (week 0), Week 72]

    Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

71. Change in Creatinine (Umol/L) [Baseline (week 0), Week 72]

    Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

72. Change in Estimated Glomerular Filtration Rate (eGFR) [Baseline (week 0), Week 72]

    Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

73. Change in Creatine Kinase [Baseline (week 0), Week 72]

    Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

74. Change in Urea [Baseline (week 0), Week 72]

    Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

75. Change in Total Bilirubin (mg/dL) [Baseline (week 0), Week 72]

    Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

76. Change in Total Bilirubin (Umol/L) [Baseline (week 0), Week 72]

    Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

77. Change in Alkaline Phosphatase [Baseline (week 0), Week 72]

    Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

78. Change in Ferritin [Baseline (week 0), Week 72]

    Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

79. Change in Sodium (mEq/L) [Baseline (week 0), Week 72]

    Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

80. Change in Sodium (mmol/L) [Baseline (week 0), Week 72]

    Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

81. Change in Potassium (mEq/L) [Baseline (week 0), Week 72]

    Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

82. Change in Potassium (mmol/L) [Baseline (week 0), Week 72]

    Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

83. Change in Calcium (mg/dL) [Baseline (week 0), Week 72]

    Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

84. Change in Calcium (mmol/L) [Baseline (week 0), Week 72]

    Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

85. Change in Amylase [Baseline (week 0), Week 72]

    Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

86. Change in Lipase [Baseline (week 0), Week 72]

    Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

87. Change in Calcitonin [Baseline (week 0), Week 72]

    Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Chandler	Arizona	United States	85224
3	Novo Nordisk Investigational Site	Tucson	Arizona	United States	85712
4	Novo Nordisk Investigational Site	Coronado	California	United States	92118
5	Novo Nordisk Investigational Site	Costa Mesa	California	United States	92627
6	Novo Nordisk Investigational Site	La Mesa	California	United States	91942
7	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
8	Novo Nordisk Investigational Site	Northridge	California	United States	91325
9	Novo Nordisk Investigational Site	Panorama City	California	United States	91402
10	Novo Nordisk Investigational Site	Rialto	California	United States	92377
11	Novo Nordisk Investigational Site	Boca Raton	Florida	United States	33434
12	Novo Nordisk Investigational Site	Gainesville	Florida	United States	32610
13	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32207
14	Novo Nordisk Investigational Site	Lakewood Ranch	Florida	United States	34211
15	Novo Nordisk Investigational Site	Miami	Florida	United States	33014
16	Novo Nordisk Investigational Site	Miami	Florida	United States	33136
17	Novo Nordisk Investigational Site	Ocoee	Florida	United States	34761
18	Novo Nordisk Investigational Site	Sarasota	Florida	United States	34240
19	Novo Nordisk Investigational Site	Monroe	Louisiana	United States	71201
20	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21202
21	Novo Nordisk Investigational Site	Detroit	Michigan	United States	48202
22	Novo Nordisk Investigational Site	Rochester	Minnesota	United States	55905
23	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68198
24	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89106
25	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89109
26	Novo Nordisk Investigational Site	Manhasset	New York	United States	11030
27	Novo Nordisk Investigational Site	Danville	Pennsylvania	United States	17822-2111
28	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15213
29	Novo Nordisk Investigational Site	Hermitage	Tennessee	United States	37076
30	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
31	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
32	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-9302
33	Novo Nordisk Investigational Site	Houston	Texas	United States	77030
34	Novo Nordisk Investigational Site	Houston	Texas	United States	77058
35	Novo Nordisk Investigational Site	Rollingwood	Texas	United States	78746
36	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
37	Novo Nordisk Investigational Site	Burlington	Vermont	United States	05401
38	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23249
39	Novo Nordisk Investigational Site	Seattle	Washington	United States	98104
40	Novo Nordisk Investigational Site	Camperdown	New South Wales	Australia	2050
41	Novo Nordisk Investigational Site	Kingswood	New South Wales	Australia	2747
42	Novo Nordisk Investigational Site	Westmead	New South Wales	Australia	2145
43	Novo Nordisk Investigational Site	Box Hill	Victoria	Australia	3128
44	Novo Nordisk Investigational Site	Fitzroy	Victoria	Australia	3065
45	Novo Nordisk Investigational Site	Graz		Austria	8036
46	Novo Nordisk Investigational Site	Salzburg		Austria	5020
47	Novo Nordisk Investigational Site	Wien		Austria	1030
48	Novo Nordisk Investigational Site	Bruxelles		Belgium	1070
49	Novo Nordisk Investigational Site	Bruxelles		Belgium	1200
50	Novo Nordisk Investigational Site	Edegem		Belgium	2650
51	Novo Nordisk Investigational Site	Gent		Belgium	9000
52	Novo Nordisk Investigational Site	Sofia		Bulgaria	1407
53	Novo Nordisk Investigational Site	Sofia		Bulgaria	1431
54	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2N 4Z6
55	Novo Nordisk Investigational Site	Winnipeg	Manitoba	Canada	R3E 3P4
56	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 2Y9
57	Novo Nordisk Investigational Site	Brampton	Ontario	Canada	L6T 0G1
58	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8S 4K1
59	Novo Nordisk Investigational Site	London	Ontario	Canada	N6A 5A5
60	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M5G 2C4
61	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M6H 3M1
62	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4A 3J1
63	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
64	Novo Nordisk Investigational Site	Hvidovre		Denmark	2650
65	Novo Nordisk Investigational Site	Helsinki		Finland	00290
66	Novo Nordisk Investigational Site	Besançon		France	25000
67	Novo Nordisk Investigational Site	Clermont-Ferrand		France	63003
68	Novo Nordisk Investigational Site	Lyon Cedex 4		France	69317
69	Novo Nordisk Investigational Site	MARSEILLE cedex 08		France	13285
70	Novo Nordisk Investigational Site	Montpellier		France	34090
71	Novo Nordisk Investigational Site	NICE cedex 3		France	06202
72	Novo Nordisk Investigational Site	Paris		France	75571
73	Novo Nordisk Investigational Site	Paris		France	75651
74	Novo Nordisk Investigational Site	Pessac		France	33604
75	Novo Nordisk Investigational Site	Toulouse		France	31059
76	Novo Nordisk Investigational Site	Venissieux		France	69200
77	Novo Nordisk Investigational Site	Athens		Greece	10676
78	Novo Nordisk Investigational Site	Athens		Greece	GR-11527
79	Novo Nordisk Investigational Site	Goudi, Athens		Greece	GR-115 27
80	Novo Nordisk Investigational Site	Larissa		Greece	GR-41110
81	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54621
82	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54642
83	Novo Nordisk Investigational Site	Asahikawa-shi, Hokkaido		Japan	078-8510
84	Novo Nordisk Investigational Site	Fukui-shi, Fukui		Japan	918-8503
85	Novo Nordisk Investigational Site	Kamigyo-ku, Kyoto		Japan	602-8566
86	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto		Japan	862-8655
87	Novo Nordisk Investigational Site	Nagakute-shi, Aichi		Japan	480-1195
88	Novo Nordisk Investigational Site	Nara-shi, Nara		Japan	630-8305
89	Novo Nordisk Investigational Site	Nishinomiya-shi, Hyogo		Japan	663-8501
90	Novo Nordisk Investigational Site	Osaka-shi, Osaka		Japan	545-8586
91	Novo Nordisk Investigational Site	Otsu-shi, Shiga		Japan	520-0804
92	Novo Nordisk Investigational Site	Saga-shi, Saga		Japan	849-8501
93	Novo Nordisk Investigational Site	Shimonoseki-shi, Yamaguchi		Japan	750-0061
94	Novo Nordisk Investigational Site	Suita-shi, Osaka		Japan	564-0013
95	Novo Nordisk Investigational Site	Suita-shi, Osaka		Japan	565-0862
96	Novo Nordisk Investigational Site	Takamatsu-shi, Kagawa		Japan	760-8557
97	Novo Nordisk Investigational Site	Toyoake-shi, Aichi		Japan	470-1192
98	Novo Nordisk Investigational Site	Alkmaar		Netherlands	1815 JD
99	Novo Nordisk Investigational Site	Amstelveen		Netherlands	1186 AM
100	Novo Nordisk Investigational Site	Amsterdam		Netherlands	1105 AZ
101	Novo Nordisk Investigational Site	Delft		Netherlands	2625 AD
102	Novo Nordisk Investigational Site	Groningen		Netherlands	9713 GZ
103	Novo Nordisk Investigational Site	Leiden		Netherlands	2333 ZA
104	Novo Nordisk Investigational Site	Maastricht		Netherlands	6229 HX
105	Novo Nordisk Investigational Site	Nijmegen		Netherlands	6525 GA
106	Novo Nordisk Investigational Site	San Juan		Puerto Rico	00927
107	Novo Nordisk Investigational Site	Barnaul		Russian Federation	656045
108	Novo Nordisk Investigational Site	Kazan		Russian Federation	420012
109	Novo Nordisk Investigational Site	Kemerovo		Russian Federation	650066
110	Novo Nordisk Investigational Site	Krasnoyarsk		Russian Federation	660022
111	Novo Nordisk Investigational Site	Moscow		Russian Federation	111123
112	Novo Nordisk Investigational Site	Moscow		Russian Federation	121170
113	Novo Nordisk Investigational Site	Moscow		Russian Federation	121293
114	Novo Nordisk Investigational Site	Moscow		Russian Federation	123423
115	Novo Nordisk Investigational Site	Moscow		Russian Federation	125367
116	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630005
117	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630099
118	Novo Nordisk Investigational Site	Penza		Russian Federation	440026
119	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	190013
120	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194356
121	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194358
122	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	195067
123	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	197110
124	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	197342
125	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	199226
126	Novo Nordisk Investigational Site	Saratov		Russian Federation	410039
127	Novo Nordisk Investigational Site	Saratov		Russian Federation	410053
128	Novo Nordisk Investigational Site	Stavropol		Russian Federation	355017
129	Novo Nordisk Investigational Site	Stavropol		Russian Federation	355035
130	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634028
131	Novo Nordisk Investigational Site	Ulianovsk		Russian Federation	432063
132	Novo Nordisk Investigational Site	Yoshkar-Ola		Russian Federation	424004
133	Novo Nordisk Investigational Site	Madrid		Spain	28034
134	Novo Nordisk Investigational Site	Majadahonda		Spain	28222
135	Novo Nordisk Investigational Site	Santander		Spain	39008
136	Novo Nordisk Investigational Site	Santiago de Compostela		Spain	15706
137	Novo Nordisk Investigational Site	Sevilla		Spain	41013
138	Novo Nordisk Investigational Site	Valencia		Spain	46026
139	Novo Nordisk Investigational Site	Göteborg		Sweden	413 45
140	Novo Nordisk Investigational Site	Malmö		Sweden	205 02
141	Novo Nordisk Investigational Site	Stockholm		Sweden	112 81
142	Novo Nordisk Investigational Site	Stockholm		Sweden	14186
143	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B15 2TH
144	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B9 5SS
145	Novo Nordisk Investigational Site	Bolton		United Kingdom	BL4 0JR
146	Novo Nordisk Investigational Site	Cambridge		United Kingdom	CB2 2QQ
147	Novo Nordisk Investigational Site	Derby		United Kingdom	DE22 3NE
148	Novo Nordisk Investigational Site	Dundee		United Kingdom	DD1 9SY
149	Novo Nordisk Investigational Site	Edinburgh		United Kingdom	EH16 4SA
150	Novo Nordisk Investigational Site	Glasgow		United Kingdom	G31 2ER
151	Novo Nordisk Investigational Site	Hull		United Kingdom	HU3 2GZ
152	Novo Nordisk Investigational Site	Leeds		United Kingdom	LS9 7TF
153	Novo Nordisk Investigational Site	London		United Kingdom	NW3 2QG
154	Novo Nordisk Investigational Site	London		United Kingdom	SE1 7EH
155	Novo Nordisk Investigational Site	London		United Kingdom	SE5 9RS
156	Novo Nordisk Investigational Site	Nottingham		United Kingdom	NG7 2UH
157	Novo Nordisk Investigational Site	Portsmouth		United Kingdom	PO6 3LY
158	Novo Nordisk Investigational Site	Swansea		United Kingdom	SA2 8PP

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 9, 2018
• Statistical Analysis Plan - Feb 27, 2020

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02970942
• Other Study ID Numbers: NN9931-4296; 2016-000685-39; U1111-1179-7464
• First Posted: Nov 22, 2016
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Liver Diseases

Study Results

Participant Flow

Recruitment Details

The trial was conducted at 114 sites in 16 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Australia (4/ 3); Austria (3/ 3); Belgium (4/ 4); Bulgaria (2/ 2); Canada (9/ 7); Denmark (2/ 2); Finland (1/ 1); France (8/ 6); Greece (5/ 5); Japan (13/ 12); Netherlands (7/ 5); Russian Federation (25/ 17); Spain (6/ 5); Sweden (3/ 2); United Kingdom (15/ 11); United States (36/ 29).

Pre-assignment Detail

Participants were randomised in a 3:3:3:1:1:1 ratio to receive once-daily semaglutide or placebo subcutaneously. After randomisation, the participants entered a dose-escalation period, with increase in dose every 4 weeks until the target dose was reached.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Period Title: Overall Study
STARTED	80	78	82	80
Full Analysis Set	80	78	82	80
Safety Analysis Set	80	78	81	80
Exposed	80	78	81	80
COMPLETED	76	72	77	77
NOT COMPLETED	4	6	5	3

Baseline Characteristics

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo	Total
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.	Total of all reporting groups
Overall Participants	80	78	82	80	320
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (10.9)	58.1 (9.9)	54.3 (10.2)	52.4 (10.8)	55.0 (10.6)
Sex: Female, Male (Count of Participants)
Female	51 63.8%	52 66.7%	47 57.3%	44 55%	194 60.6%
Male	29 36.3%	26 33.3%	35 42.7%	36 45%	126 39.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 8.8%	10 12.8%	14 17.1%	9 11.3%	40 12.5%
Not Hispanic or Latino	69 86.3%	63 80.8%	65 79.3%	66 82.5%	263 82.2%
Unknown or Not Reported	4 5%	5 6.4%	3 3.7%	5 6.3%	17 5.3%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.3%	2 2.4%	0 0%	3 0.9%
Asian	10 12.5%	12 15.4%	14 17.1%	12 15%	48 15%
Black or African American	1 1.3%	1 1.3%	0 0%	0 0%	2 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
White	65 81.3%	59 75.6%	62 75.6%	62 77.5%	248 77.5%
Other	0 0%	0 0%	1 1.2%	1 1.3%	2 0.6%
Not applicable	4 5%	5 6.4%	3 3.7%	5 6.3%	17 5.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
Description	NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	After 72 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	57	59	56	58
Yes	40.4 50.5%	35.6 45.6%	58.9 71.8%	17.2 21.5%
No	54.4 68%	47.5 60.9%	30.4 37.1%	74.1 92.6%
Missing	5.3 6.6%	16.9 21.7%	10.7 13%	8.6 10.8%

2. Secondary Outcome

Title	Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
Description	NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.
Time Frame	After 72 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	57	59	56	58
Yes	49.1 61.4%	32.2 41.3%	42.9 52.3%	32.8 41%
No	45.6 57%	50.8 65.1%	46.4 56.6%	58.6 73.3%
Missing	5.3 6.6%	16.9 21.7%	10.7 13%	8.6 10.8%

3. Secondary Outcome

Title	Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Description	Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	71.3 89.1%	79.5 101.9%	82.9 101.1%	43.8 54.8%
Worsening	7.5 9.4%	2.6 3.3%	3.7 4.5%	16.3 20.4%
No change	13.8 17.3%	5.1 6.5%	1.2 1.5%	27.5 34.4%
Missing	7.5 9.4%	12.8 16.4%	12.2 14.9%	12.5 15.6%

4. Secondary Outcome

Title	Percentage of Participants With Change in Steatosis
Description	Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	52.5 65.6%	60.3 77.3%	63.4 77.3%	26.3 32.9%
Worsening	6.3 7.9%	2.6 3.3%	3.7 4.5%	15.0 18.8%
No change	33.8 42.3%	24.4 31.3%	20.7 25.2%	46.3 57.9%
Missing	7.5 9.4%	12.8 16.4%	12.2 14.9%	12.5 15.6%

5. Secondary Outcome

Title	Percentage of Participants With Change in Lobular Inflammation
Description	Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	41.3 51.6%	47.4 60.8%	37.8 46.1%	26.3 32.9%
Worsening	7.5 9.4%	7.7 9.9%	6.1 7.4%	17.5 21.9%
No change	43.8 54.8%	32.1 41.2%	43.9 53.5%	45.0 56.3%
Missing	7.5 9.4%	12.8 16.4%	12.2 14.9%	11.3 14.1%

6. Secondary Outcome

Title	Percentage of Participants With Change in Hepatocyte Ballooning
Description	Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	61.3 76.6%	70.5 90.4%	74.4 90.7%	38.8 48.5%
Worsening	2.5 3.1%	2.6 3.3%	1.2 1.5%	2.5 3.1%
No change	28.8 36%	14.1 18.1%	12.2 14.9%	46.3 57.9%
Missing	7.5 9.4%	12.8 16.4%	12.2 14.9%	12.5 15.6%

7. Secondary Outcome

Title	Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
Description	Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	46.3 57.9%	32.1 41.2%	42.7 52.1%	31.3 39.1%
Worsening	10.0 12.5%	7.7 9.9%	4.9 6%	18.8 23.5%
No change	36.3 45.4%	42.3 54.2%	36.6 44.6%	37.5 46.9%
Missing	7.5 9.4%	17.9 22.9%	15.9 19.4%	12.5 15.6%

8. Secondary Outcome

Title	Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
Description	Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Improvement	62.5 78.1%	71.8 92.1%	72.0 87.8%	42.5 53.1%
Worsening	7.5 9.4%	3.8 4.9%	1.2 1.5%	11.3 14.1%
No change	22.5 28.1%	11.5 14.7%	14.6 17.8%	33.8 42.3%
Missing	7.5 9.4%	12.8 16.4%	12.2 14.9%	12.5 15.6%

9. Secondary Outcome

Title	Change in Fibrosis-4 Score
Description	Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	63	72	67
Geometric Mean (Geometric Coefficient of Variation) [Ratio of fibrosis-4 score]	0.81 (36.8)	0.77 (32.4)	0.77 (31.3)	0.95 (43.1)

10. Secondary Outcome

Title	Change in NAFLD Fibrosis Score (NFS)
Description	Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	63	72	66
Mean (Standard Deviation) [Score on a scale]	-0.322 (0.819)	-0.617 (0.691)	-0.475 (0.770)	-0.040 (0.844)

11. Secondary Outcome

Title	Change in Alanine Aminotransferase (ALT)
Description	Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of ALT]	0.62 (62.7)	0.57 (62.1)	0.40 (68.2)	0.80 (60.3)

12. Secondary Outcome

Title	Change in Aspartate Aminotransferase (AST)
Description	Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	69	77	74
Geometric Mean (Geometric Coefficient of Variation) [Ratio of AST]	0.66 (55.1)	0.63 (46.6)	0.50 (45.8)	0.84 (62.3)

13. Secondary Outcome

Title	Change in Gamma Glutamyl Transferase (GGT)
Description	Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of GGT]	0.76 (52.0)	0.64 (51.6)	0.48 (60.2)	0.92 (46.6)

14. Secondary Outcome

Title	Change in Albumin
Description	Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of albumin]	1.02 (5.6)	1.01 (6.0)	1.01 (5.4)	1.02 (6.0)

15. Secondary Outcome

Title	Change in International Normalized Ratio (INR)
Description	Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	76	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of INR]	0.97 (18.8)	0.96 (11.8)	0.93 (22.3)	0.99 (19.3)

16. Secondary Outcome

Title	Change in Enhanced Liver Fibrosis (ELF)
Description	Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) ≥ 7.7 - < 9.8: Moderate fibrosis; c) ≥ 9.8 - < 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	70	76	75
Mean (Standard Deviation) [score on a scale]	-0.4 (0.7)	-0.4 (0.8)	-0.6 (0.8)	0.1 (0.7)

17. Secondary Outcome

Title	Change in Cytokeratin 18 (CK-18) Fragments
Description	Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	76	74
M30	0.52 (84.2)	0.50 (76.4)	0.40 (74.5)	0.78 (106.9)
M65	0.51 (73.1)	0.52 (62.5)	0.38 (65.6)	0.71 (83.7)

18. Secondary Outcome

Title	Change in microRNA 122 (miR-122)
Description	Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	73	71	76	74
Geometric Mean (Geometric Coefficient of Variation) [Ratio of miR-122]	0.86 (151.8)	0.74 (203.1)	0.58 (161.3)	1.28 (194.3)

19. Secondary Outcome

Title	Change in Interleukin-1 Receptor (IL-1R) Antagonist
Description	Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	69	65	74	69
Geometric Mean (Geometric Coefficient of Variation) [Ratio of IL-1R antagonist]	0.87 (49.3)	0.85 (37.5)	0.73 (47.9)	0.94 (41.7)

20. Secondary Outcome

Title	Change in Monocyte Chemoattractant Protein 1 (MCP-1)
Description	Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	75	71	76	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of MCP-1]	1.07 (23.3)	1.08 (29.8)	0.99 (30.7)	1.04 (26.4)

21. Secondary Outcome

Title	Change in Fibroblast Growth Factor 21 (FGF-21)
Description	Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	74
Geometric Mean (Geometric Coefficient of Variation) [Ratio of FGF-21]	0.72 (86.1)	0.61 (104.1)	0.55 (91.3)	0.76 (64.8)

22. Secondary Outcome

Title	Change in Liver Stiffness Assessed by FibroScan®
Description	Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	47	49	46	45
Geometric Mean (Geometric Coefficient of Variation) [Ratio of liver stiffness]	0.72 (49.3)	0.64 (52.2)	0.66 (58.4)	1.18 (71.2)

23. Secondary Outcome

Title	Change in Liver Steatosis Assessed by FibroScan®
Description	Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	34	37	33	35
Mean (Standard Deviation) [Decibels per meter]	-5.8 (41.1)	-50.9 (64.3)	-42.1 (73.3)	-18.7 (43.3)

24. Secondary Outcome

Title	Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
Description	Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Yes	43.8 54.8%	62.8 80.5%	76.8 93.7%	16.3 20.4%
No	51.3 64.1%	28.2 36.2%	17.1 20.9%	78.8 98.5%
Missing	5.0 6.3%	9.0 11.5%	6.1 7.4%	5.0 6.3%

25. Secondary Outcome

Title	Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
Description	Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Yes	17.5 21.9%	38.5 49.4%	59.8 72.9%	2.5 3.1%
No	77.5 96.9%	52.6 67.4%	34.1 41.6%	92.5 115.6%
Missing	5.0 6.3%	9.0 11.5%	6.1 7.4%	5.0 6.3%

26. Secondary Outcome

Title	Change in Body Weight
Description	Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	76
Mean (Standard Deviation) [Kilograms]	-4.8 (6.0)	-9.4 (9.2)	-12.3 (8.6)	-1.0 (4.9)

27. Secondary Outcome

Title	Change in Waist Circumference
Description	Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	69	77	75
Mean (Standard Deviation) [Centimeters]	-3.9 (6.3)	-7.1 (8.9)	-11.4 (9.3)	-1.7 (6.2)

28. Secondary Outcome

Title	Change in Body Mass Index (BMI)
Description	Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	76
Mean (Standard Deviation) [Kilograms per square meter]	-1.8 (2.2)	-3.5 (3.4)	-4.6 (3.3)	-0.3 (1.8)

29. Secondary Outcome

Title	Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Description	Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	46	45	47	47
Mean (Standard Deviation) [Percentage point of HbA1c]	-0.7 (1.1)	-1.2 (0.9)	-1.2 (1.0)	-0.0 (1.0)

30. Secondary Outcome

Title	Change in HbA1c (Millimoles Per Mole)
Description	Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	46	45	47	47
Mean (Standard Deviation) [millimoles per mole]	-7.9 (12.2)	-12.8 (9.5)	-12.8 (11.3)	-0.3 (10.7)

31. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG)
Description	Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	45	44	47	48
Mean (Standard Deviation) [Millimoles per liter]	-1.39 (2.53)	-2.17 (1.82)	-2.09 (2.68)	-0.34 (2.72)

32. Secondary Outcome

Title	Change in Fasting Glucagon
Description	Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	45	45	47	47
Geometric Mean (Geometric Coefficient of Variation) [Ratio of glucagon]	0.78 (76.8)	0.65 (94.8)	0.63 (100.4)	1.04 (80.8)

33. Secondary Outcome

Title	Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Description	Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	42	43	44	45
Geometric Mean (Geometric Coefficient of Variation) [Ratio of HOMA-IR]	0.77 (62.2)	0.60 (77.6)	0.58 (94.6)	0.81 (127.5)

34. Secondary Outcome

Title	Change in Diastolic Blood Pressure (DBP)
Description	Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	70	77	76
Mean (Standard Deviation) [Millimeters of mercury]	0 (10)	-2 (11)	-2 (9)	-1 (10)

35. Secondary Outcome

Title	Change in Systolic Blood Pressure (SBP)
Description	Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	70	77	76
Mean (Standard Deviation) [Millimeters of mercury]	-2 (16)	-7 (18)	-6 (16)	-2 (15)

36. Secondary Outcome

Title	Change in Total Cholesterol
Description	Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	75	68	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total cholesterol]	0.98 (17.1)	1.00 (20.3)	0.93 (15.7)	0.93 (18.8)

37. Secondary Outcome

Title	Change in Low Density Lipoprotein (LDL) Cholesterol
Description	Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	73	68	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of LDL cholesterol]	0.96 (22.9)	1.01 (34.9)	0.92 (25.5)	0.90 (30.7)

38. Secondary Outcome

Title	Change in High Density Lipoprotein (HDL) Cholesterol
Description	Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	68	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of HDL cholesterol]	1.04 (16.1)	1.05 (12.9)	1.09 (16.4)	1.01 (12.9)

39. Secondary Outcome

Title	Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Description	Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	73	68	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of VLDL cholesterol]	0.89 (31.9)	0.90 (36.1)	0.74 (38.2)	0.93 (36.7)

40. Secondary Outcome

Title	Change in Triglycerides
Description	Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	68	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of triglycerides]	0.88 (34.1)	0.89 (37.6)	0.73 (41.4)	0.95 (36.9)

41. Secondary Outcome

Title	Change in Free Fatty Acids
Description	Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	72	68	74	72
Geometric Mean (Geometric Coefficient of Variation) [Ratio of free fatty acids]	0.83 (54.8)	0.92 (73.2)	0.72 (80.8)	1.05 (75.9)

42. Secondary Outcome

Title	Change in High Sensitivity C-reactive Protein (hsCRP)
Description	Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	76	71	77	75
Geometric Mean (Geometric Coefficient of Variation) [Ratio of hsCRP]	0.78 (114.6)	0.50 (124.1)	0.41 (114.6)	0.91 (85.8)

43. Secondary Outcome

Title	Change in Short Form 36 (SF-36) Score
Description	Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	82	80
Mental component sum	2.2 (8.5)	0.6 (9.2)	1.2 (9.5)	-0.4 (8.9)
Physical component sum	2.1 (7.0)	1.1 (7.3)	3.9 (7.1)	-0.1 (8.3)
Physical functioning	1.8 (7.8)	2.0 (7.3)	2.8 (7.8)	-0.4 (8.2)
Role functioning	2.1 (6.9)	0.5 (9.3)	2.2 (8.1)	-0.3 (9.4)
Bodily pain	1.3 (10.9)	1.2 (10.1)	3.4 (7.9)	-1.3 (10.2)
General health	7.2 (14.8)	2.3 (17.8)	9.0 (17.4)	4.3 (16.5)
Vitality	2.3 (8.6)	0.6 (9.4)	4.6 (9.8)	-0.2 (10.1)
Social functioning	3.7 (9.0)	-0.1 (9.9)	2.2 (9.4)	-1.6 (8.3)
Role emotional	2.2 (8.9)	0.6 (9.1)	0.5 (9.5)	-0.3 (8.5)
Mental health	1.2 (8.9)	1.5 (8.2)	1.3 (9.5)	-0.2 (9.7)

44. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAEs)
Description	An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Number [events]	525	577	511	445

45. Secondary Outcome

Title	Number of Treatment-emergent Hypoglycaemic Episodes
Description	Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	49	51	49	50
Number [episodes]	54	30	66	18

46. Secondary Outcome

Title	Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Description	Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	49	51	49	50
Number [episodes]	3	5	17	2

47. Secondary Outcome

Title	Number of Treatment-emergent Severe Hypoglycaemic Episodes
Description	Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	49	51	49	50
Number [episodes]	2	2	0	0

48. Secondary Outcome

Title	Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Description	Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Count of Participants [Participants]	1 1.3%	6 7.7%	2 2.4%	0 0%

49. Secondary Outcome

Title	Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Description	Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Measure Participants	80	78	81
Yes	4 5%	1 1.3%	2 2.4%
No	76 95%	77 98.7%	79 96.3%

50. Secondary Outcome

Title	Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Description	Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Measure Participants	80	78	81
Yes	0 0%	0 0%	0 0%
No	80 100%	78 100%	81 98.8%

51. Secondary Outcome

Title	Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Description	Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Measure Participants	80	78	81
Yes	4 5%	0 0%	2 2.4%
No	76 95%	78 100%	79 96.3%

52. Secondary Outcome

Title	Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Description	Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame	From week 0 to week 79

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Measure Participants	80	78	81
Yes	0 0%	0 0%	0 0%
No	80 100%	78 100%	81 98.8%

53. Secondary Outcome

Title	Change in Pulse From Baseline to Week 72
Description	Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	73	63	72	71
Mean (Standard Deviation) [beats per minute (bpm)]	2.2 (10.9)	2.1 (9.0)	0.9 (9.6)	-0.3 (9.1)

54. Secondary Outcome

Title	Percentage of Participants With Change in Electrocardiogram (ECG)
Description	A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Week 0: Normal	58.8 73.5%	60.3 77.3%	66.7 81.3%	63.8 79.8%
Week 0: Abnormal NCS	41.3 51.6%	39.7 50.9%	32.1 39.1%	36.3 45.4%
Week 0: Abnormal CS	0.0 0%	0.0 0%	1.2 1.5%	0.0 0%
Week 72: Normal	64.9 81.1%	65.1 83.5%	74.6 91%	60.0 75%
Week 72: Abnormal NCS	35.1 43.9%	34.9 44.7%	23.9 29.1%	38.6 48.3%
Week 72: Abnormal CS	0.0 0%	0.0 0%	1.4 1.7%	1.4 1.8%

55. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Cardiovascular System
Description	Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Week -6: Normal	87.5 109.4%	93.6 120%	92.6 112.9%	92.5 115.6%
Week -6: Abnormal NCS	11.3 14.1%	5.1 6.5%	7.4 9%	6.3 7.9%
Week -6: Abnormal CS	1.3 1.6%	1.3 1.7%	0.0 0%	1.3 1.6%
Week 72: Normal	87.8 109.8%	96.9 124.2%	94.4 115.1%	90.1 112.6%
Week 72: Abnormal NCS	12.2 15.3%	3.1 4%	5.6 6.8%	8.5 10.6%
Week 72: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	1.4 1.8%

56. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Description	Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	79	80
Week -6: Normal	92.5 115.6%	94.8 121.5%	98.7 120.4%	95.0 118.8%
Week -6: Abnormal NCS	5.0 6.3%	5.2 6.7%	1.3 1.6%	3.8 4.8%
Week -6: Abnormal CS	2.5 3.1%	0.0 0%	0.0 0%	1.3 1.6%
Week 72: Normal	94.6 118.3%	93.7 120.1%	98.6 120.2%	92.9 116.1%
Week 72: Abnormal NCS	5.4 6.8%	4.8 6.2%	1.4 1.7%	7.1 8.9%
Week 72: Abnormal CS	0.0 0%	1.6 2.1%	0.0 0%	0.0 0%

57. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Description	Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	81	80
Week -6: Normal	82.5 103.1%	83.1 106.5%	84.0 102.4%	86.3 107.9%
Week -6: Abnormal NCS	13.8 17.3%	15.6 20%	16.0 19.5%	12.5 15.6%
Week -6: Abnormal CS	3.8 4.8%	1.3 1.7%	0.0 0%	1.3 1.6%
Week 72: Normal	89.2 111.5%	81.0 103.8%	87.5 106.7%	84.5 105.6%
Week 72: Abnormal NCS	10.8 13.5%	19.0 24.4%	12.5 15.2%	14.1 17.6%
Week 72: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	1.4 1.8%

58. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: General Appearance
Description	Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Week -6: Normal	83.8 104.8%	85.9 110.1%	79.0 96.3%	80.0 100%
Week -6: Abnormal NCS	16.3 20.4%	12.8 16.4%	21.0 25.6%	20.0 25%
Week -6: Abnormal CS	0.0 0%	1.3 1.7%	0.0 0%	0.0 0%
Week 72: Normal	83.8 104.8%	90.6 116.2%	90.3 110.1%	76.1 95.1%
Week 72: Abnormal NCS	16.2 20.3%	6.3 8.1%	9.7 11.8%	23.9 29.9%
Week 72: Abnormal CS	0.0 0%	3.1 4%	0.0 0%	0.0 0%

59. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Description	Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	80	80
Week -6: Normal	97.5 121.9%	94.8 121.5%	98.8 120.5%	97.5 121.9%
Week -6: Abnormal NCS	2.5 3.1%	5.2 6.7%	1.3 1.6%	2.5 3.1%
Week -6: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Week 72: Normal	94.5 118.1%	96.8 124.1%	98.6 120.2%	98.6 123.3%
Week 72: Abnormal NCS	4.1 5.1%	3.2 4.1%	1.4 1.7%	0.0 0%
Week 72: Abnormal CS	1.4 1.8%	0.0 0%	0.0 0%	1.4 1.8%

60. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Description	Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	78	80
Week -6: Normal	100.0 125%	98.7 126.5%	100.0 122%	100.0 125%
Week -6: Abnormal NCS	0.0 0%	1.3 1.7%	0.0 0%	0.0 0%
Week -6: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Week 72: Normal	100.0 125%	100.0 128.2%	100.0 122%	100.0 125%
Week 72: Abnormal NCS	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Week 72: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%

61. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Description	Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	79	80
Week -6: Normal	95.0 118.8%	96.1 123.2%	94.9 115.7%	95.0 118.8%
Week -6: Abnormal NCS	3.8 4.8%	3.9 5%	5.1 6.2%	3.8 4.8%
Week -6: Abnormal CS	1.3 1.6%	0.0 0%	0.0 0%	1.3 1.6%
Week 72: Normal	94.6 118.3%	96.8 124.1%	100.0 122%	95.8 119.8%
Week 72: Abnormal NCS	5.4 6.8%	3.2 4.1%	0.0 0%	4.2 5.3%
Week 72: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%

62. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Respiratory System
Description	Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Week -6: Normal	100.0 125%	100.0 128.2%	100.0 122%	97.5 121.9%
Week -6: Abnormal NCS	0.0 0%	0.0 0%	0.0 0%	2.5 3.1%
Week -6: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Week 72: Normal	98.6 123.3%	96.9 124.2%	98.6 120.2%	98.6 123.3%
Week 72: Abnormal NCS	0.0 0%	3.1 4%	1.4 1.7%	1.4 1.8%
Week 72: Abnormal CS	1.4 1.8%	0.0 0%	0.0 0%	0.0 0%

63. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Skin
Description	Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	78	81	80
Week -6: Normal	96.3 120.4%	92.3 118.3%	85.2 103.9%	90.0 112.5%
Week -6: Abnormal NCS	2.5 3.1%	6.4 8.2%	13.6 16.6%	10.0 12.5%
Week -6: Abnormal CS	1.3 1.6%	1.3 1.7%	1.2 1.5%	0.0 0%
Week 72: Normal	94.6 118.3%	87.5 112.2%	90.0 109.8%	88.7 110.9%
Week 72: Abnormal NCS	4.1 5.1%	10.9 14%	8.6 10.5%	11.3 14.1%
Week 72: Abnormal CS	1.4 1.8%	1.6 2.1%	1.4 1.7%	0.0 0%

64. Secondary Outcome

Title	Percentage of Participants With Change in Physical Examination: Thyroid Gland
Description	Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Week -6, week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	80	77	80	80
Week -6: Normal	88.8 111%	97.4 124.9%	97.5 118.9%	98.8 123.5%
Week -6: Abnormal NCS	10.0 12.5%	2.6 3.3%	2.5 3%	0.0 0%
Week -6: Abnormal CS	1.3 1.6%	0.0 0%	0.0 0%	1.3 1.6%
Week 72: Normal	94.6 118.3%	98.4 126.2%	97.1 118.4%	98.6 123.3%
Week 72: Abnormal NCS	5.4 6.8%	1.6 2.1%	2.9 3.5%	1.4 1.8%
Week 72: Abnormal CS	0.0 0%	0.0 0%	0.0 0%	0.0 0%

65. Secondary Outcome

Title	Change in Haematocrit
Description	Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	70	68
Mean (Standard Deviation) [Percentage of haematocrit in blood]	-0.79 (3.14)	-0.71 (2.77)	-1.43 (3.50)	-0.41 (3.53)

66. Secondary Outcome

Title	Change in Haemoglobin (g/dL)
Description	Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	70	68
Mean (Standard Deviation) [Grams per deciliter (g/dL)]	0.18 (1.05)	0.08 (0.89)	-0.07 (0.98)	0.21 (1.08)

67. Secondary Outcome

Title	Change in Haemoglobin (mmol/L)
Description	Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	70	68
Mean (Standard Deviation) [millimoles per liter (mmol/L)]	0.11 (0.65)	0.05 (0.55)	-0.05 (0.61)	0.13 (0.67)

68. Secondary Outcome

Title	Change in Leukocytes
Description	Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	70	68
Mean (Standard Deviation) [10^9 cells per liter (10^9/L)]	0.489 (1.564)	0.260 (1.343)	-0.047 (1.532)	0.075 (1.733)

69. Secondary Outcome

Title	Change in Thrombocytes
Description	Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	69	67
Mean (Standard Deviation) [10^9 cells per liter (10^9/L)]	8.8 (46.9)	14.6 (34.8)	9.0 (44.9)	0.3 (43.7)

70. Secondary Outcome

Title	Change in Erythrocytes
Description	Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	71	59	70	68
Mean (Standard Deviation) [10^12 cells per liter (10^12/L)]	0.038 (0.292)	0.004 (0.220)	-0.034 (0.334)	0.054 (0.314)

71. Secondary Outcome

Title	Change in Creatinine (mg/dL)
Description	Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of creatinine]	1.018 (30.70)	1.069 (42.19)	1.026 (35.17)	1.021 (33.87)

72. Secondary Outcome

Title	Change in Creatinine (Umol/L)
Description	Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of creatinine]	1.018 (30.70)	1.069 (42.19)	1.026 (35.17)	1.021 (33.87)

73. Secondary Outcome

Title	Change in Estimated Glomerular Filtration Rate (eGFR)
Description	Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of eGFR]	0.976 (28.04)	0.940 (40.47)	0.973 (31.42)	0.969 (31.24)

74. Secondary Outcome

Title	Change in Creatine Kinase
Description	Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of creatine kinase]	0.975 (73.02)	0.798 (77.96)	0.825 (74.17)	0.904 (76.04)

75. Secondary Outcome

Title	Change in Urea
Description	Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of urea]	1.018 (51.01)	0.973 (52.30)	1.042 (51.14)	1.043 (52.30)

76. Secondary Outcome

Title	Change in Total Bilirubin (mg/dL)
Description	Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total bilirubin]	0.978 (66.72)	1.011 (70.66)	0.949 (65.89)	1.040 (67.36)

77. Secondary Outcome

Title	Change in Total Bilirubin (Umol/L)
Description	Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total bilirubin]	0.978 (66.72)	1.011 (70.66)	0.949 (65.89)	1.040 (67.36)

78. Secondary Outcome

Title	Change in Alkaline Phosphatase
Description	Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of alkaline phosphatase]	0.980 (45.68)	0.931 (43.59)	0.884 (54.90)	0.992 (42.42)

79. Secondary Outcome

Title	Change in Ferritin
Description	Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of ferritin]	0.660 (99.95)	0.617 (88.70)	0.603 (88.83)	0.713 (96.91)

80. Secondary Outcome

Title	Change in Sodium (mEq/L)
Description	Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of sodium]	0.999 (12.23)	1.000 (12.13)	1.002 (11.68)	1.002 (12.91)

81. Secondary Outcome

Title	Change in Sodium (mmol/L)
Description	Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of sodium]	0.999 (12.23)	1.000 (12.13)	1.002 (11.68)	1.002 (12.91)

82. Secondary Outcome

Title	Change in Potassium (mEq/L)
Description	Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	61	72	69
Geometric Mean (Geometric Coefficient of Variation) [Ratio of potassium]	1.004 (27.00)	0.979 (29.36)	0.998 (27.81)	0.998 (27.78)

83. Secondary Outcome

Title	Change in Potassium (mmol/L)
Description	Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	61	72	69
Geometric Mean (Geometric Coefficient of Variation) [Ratio of potassium]	1.004 (27.00)	0.979 (29.36)	0.998 (27.81)	0.998 (27.78)

84. Secondary Outcome

Title	Change in Calcium (mg/dL)
Description	Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of calcium]	1.017 (20.37)	1.018 (20.49)	1.008 (20.88)	1.010 (22.79)

85. Secondary Outcome

Title	Change in Calcium (mmol/L)
Description	Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of calcium]	1.017 (20.37)	1.018 (20.49)	1.008 (20.88)	1.010 (22.79)

86. Secondary Outcome

Title	Change in Amylase
Description	Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of amylase]	1.155 (49.85)	1.120 (65.01)	1.170 (47.88)	1.051 (45.74)

87. Secondary Outcome

Title	Change in Lipase
Description	Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of lipase]	1.305 (77.43)	1.245 (87.68)	1.375 (73.88)	1.003 (66.72)

88. Secondary Outcome

Title	Change in Calcitonin
Description	Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame	Baseline (week 0), Week 72

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.

Arm/Group Title	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).	Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).	Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Measure Participants	74	62	72	70
Geometric Mean (Geometric Coefficient of Variation) [Ratio of Calcitonin]	1.040 (62.98)	0.937 (65.42)	1.000 (66.24)	0.950 (62.39)

Adverse Events

Time Frame	From week 0 to week 79 Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.
Adverse Event Reporting Description	All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.
Arm/Group Title	Semaglutide 0.1 mg		Semaglutide 0.2 mg		Semaglutide 0.4 mg		Placebo
Arm/Group Description	Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).		Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).		Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).		Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
All Cause Mortality
	Semaglutide 0.1 mg		Semaglutide 0.2 mg		Semaglutide 0.4 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		1/78 (1.3%)		0/81 (0%)		0/80 (0%)
Serious Adverse Events
	Semaglutide 0.1 mg		Semaglutide 0.2 mg		Semaglutide 0.4 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/80 (15%)		15/78 (19.2%)		12/81 (14.8%)		8/80 (10%)
Blood and lymphatic system disorders
Anaemia	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Cardiac disorders
Angina unstable	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Ventricular tachycardia	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Endocrine disorders
Basedow's disease	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Eye disorders
Cataract	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Gastrointestinal disorders
Abdominal adhesions	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Colitis	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Colitis ischaemic	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Constipation	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Diverticulum intestinal haemorrhagic	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Gastrointestinal polyp haemorrhage	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Megacolon	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Nausea	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
General disorders
Non-cardiac chest pain	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Sudden death	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Hepatobiliary disorders
Cholangitis acute	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Cholecystitis	1/80 (1.3%)	1	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Cholelithiasis	1/80 (1.3%)	1	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Immune system disorders
Sarcoidosis	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Infections and infestations
Anal abscess	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Cellulitis	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Cystitis	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Cystitis escherichia	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Diverticulitis	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Gastroenteritis	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Hepatitis E	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Pneumonia	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Sepsis	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Urosepsis	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Injury, poisoning and procedural complications
Arthropod bite	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Post procedural haematoma	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	1/80 (1.3%)	1
Metabolism and nutrition disorders
Diabetic metabolic decompensation	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Hyperglycaemia	1/80 (1.3%)	1	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Hypoglycaemia	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Back pain	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Foot deformity	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Musculoskeletal pain	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Osteoarthritis	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Endometrial adenocarcinoma	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Neurilemmoma benign	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Peripheral T-cell lymphoma unspecified	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Uterine leiomyoma	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Nervous system disorders
Diabetic neuropathy	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Epilepsy	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Lumbosacral radiculopathy	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Transient epileptic amnesia	0/80 (0%)	0	0/78 (0%)	0	1/81 (1.2%)	1	0/80 (0%)	0
Transient ischaemic attack	0/80 (0%)	0	1/78 (1.3%)	2	0/81 (0%)	0	0/80 (0%)	0
Psychiatric disorders
Bipolar disorder	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Major depression	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Suicidal ideation	1/80 (1.3%)	2	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/80 (0%)	0	2/78 (2.6%)	2	0/81 (0%)	0	0/80 (0%)	0
Calculus urinary	0/80 (0%)	0	0/78 (0%)	0	0/81 (0%)	0	1/80 (1.3%)	1
Reproductive system and breast disorders
Dysfunctional uterine bleeding	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Ovarian cyst	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Uterine polyp	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	0/80 (0%)	0
Atelectasis	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Pleural effusion	1/80 (1.3%)	1	0/78 (0%)	0	0/81 (0%)	0	0/80 (0%)	0
Other (Not Including Serious) Adverse Events
	Semaglutide 0.1 mg		Semaglutide 0.2 mg		Semaglutide 0.4 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/80 (76.3%)		64/78 (82.1%)		63/81 (77.8%)		55/80 (68.8%)
Gastrointestinal disorders
Abdominal distension	1/80 (1.3%)	1	8/78 (10.3%)	9	4/81 (4.9%)	7	4/80 (5%)	5
Abdominal pain	9/80 (11.3%)	10	8/78 (10.3%)	9	6/81 (7.4%)	7	3/80 (3.8%)	4
Abdominal pain upper	5/80 (6.3%)	5	6/78 (7.7%)	7	8/81 (9.9%)	10	3/80 (3.8%)	4
Constipation	12/80 (15%)	14	17/78 (21.8%)	22	18/81 (22.2%)	20	10/80 (12.5%)	11
Diarrhoea	23/80 (28.8%)	31	22/78 (28.2%)	30	16/81 (19.8%)	21	11/80 (13.8%)	16
Dyspepsia	4/80 (5%)	4	9/78 (11.5%)	11	4/81 (4.9%)	5	5/80 (6.3%)	7
Eructation	5/80 (6.3%)	6	6/78 (7.7%)	6	1/81 (1.2%)	1	0/80 (0%)	0
Flatulence	2/80 (2.5%)	2	5/78 (6.4%)	5	3/81 (3.7%)	3	0/80 (0%)	0
Gastrooesophageal reflux disease	3/80 (3.8%)	3	4/78 (5.1%)	5	5/81 (6.2%)	6	2/80 (2.5%)	2
Large intestine polyp	1/80 (1.3%)	1	4/78 (5.1%)	4	3/81 (3.7%)	3	0/80 (0%)	0
Nausea	24/80 (30%)	32	29/78 (37.2%)	39	33/81 (40.7%)	49	9/80 (11.3%)	10
Vomiting	14/80 (17.5%)	21	17/78 (21.8%)	26	12/81 (14.8%)	29	2/80 (2.5%)	3
General disorders
Fatigue	7/80 (8.8%)	7	8/78 (10.3%)	8	7/81 (8.6%)	8	7/80 (8.8%)	7
Injection site bruising	1/80 (1.3%)	1	5/78 (6.4%)	10	3/81 (3.7%)	4	2/80 (2.5%)	2
Pyrexia	1/80 (1.3%)	1	4/78 (5.1%)	4	1/81 (1.2%)	1	1/80 (1.3%)	1
Infections and infestations
Gastroenteritis	4/80 (5%)	4	2/78 (2.6%)	2	1/81 (1.2%)	1	2/80 (2.5%)	2
Influenza	7/80 (8.8%)	7	1/78 (1.3%)	1	3/81 (3.7%)	4	6/80 (7.5%)	6
Nasopharyngitis	11/80 (13.8%)	15	15/78 (19.2%)	21	10/81 (12.3%)	11	12/80 (15%)	22
Sinusitis	4/80 (5%)	4	7/78 (9%)	8	2/81 (2.5%)	4	1/80 (1.3%)	1
Upper respiratory tract infection	4/80 (5%)	4	6/78 (7.7%)	8	3/81 (3.7%)	4	5/80 (6.3%)	6
Urinary tract infection	5/80 (6.3%)	7	2/78 (2.6%)	2	7/81 (8.6%)	9	0/80 (0%)	0
Injury, poisoning and procedural complications
Procedural pain	6/80 (7.5%)	7	2/78 (2.6%)	2	2/81 (2.5%)	2	2/80 (2.5%)	2
Investigations
Lipase increased	4/80 (5%)	5	7/78 (9%)	8	1/81 (1.2%)	3	0/80 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	16/80 (20%)	18	18/78 (23.1%)	18	18/81 (22.2%)	22	4/80 (5%)	4
Diabetes mellitus	0/80 (0%)	0	1/78 (1.3%)	1	0/81 (0%)	0	4/80 (5%)	5
Hyperglycaemia	1/80 (1.3%)	1	2/78 (2.6%)	3	3/81 (3.7%)	6	7/80 (8.8%)	8
Musculoskeletal and connective tissue disorders
Arthralgia	0/80 (0%)	0	4/78 (5.1%)	4	8/81 (9.9%)	8	7/80 (8.8%)	7
Back pain	7/80 (8.8%)	10	5/78 (6.4%)	5	10/81 (12.3%)	10	6/80 (7.5%)	6
Muscle spasms	1/80 (1.3%)	1	1/78 (1.3%)	1	3/81 (3.7%)	3	4/80 (5%)	4
Pain in extremity	1/80 (1.3%)	1	1/78 (1.3%)	1	2/81 (2.5%)	2	5/80 (6.3%)	7
Nervous system disorders
Dizziness	6/80 (7.5%)	8	6/78 (7.7%)	8	8/81 (9.9%)	10	6/80 (7.5%)	7
Headache	7/80 (8.8%)	11	10/78 (12.8%)	13	10/81 (12.3%)	13	8/80 (10%)	10
Psychiatric disorders
Insomnia	1/80 (1.3%)	1	1/78 (1.3%)	1	4/81 (4.9%)	5	5/80 (6.3%)	5
Respiratory, thoracic and mediastinal disorders
Respiratory disorder	1/80 (1.3%)	1	0/78 (0%)	0	1/81 (1.2%)	1	4/80 (5%)	5
Vascular disorders
Hypertension	3/80 (3.8%)	3	3/78 (3.8%)	3	3/81 (3.7%)	3	4/80 (5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.