STEP 2: Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Study Details
Study Description
Brief Summary
This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Semaglutide 1.0 mg Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity. |
Drug: Semaglutide 1.0 mg
Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Drug: Placebo I (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
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Experimental: Semaglutide 2.4 mg Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity. |
Drug: Semaglutide 2.4 mg
Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Drug: Placebo II (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
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Placebo Comparator: Semaglutide placebo I/II Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity. |
Drug: Placebo I (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Drug: Placebo II (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
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Outcome Measures
Primary Outcome Measures
- Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo [At week 68]
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Secondary Outcome Measures
- Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg [Baseline (week 0) to week 68]
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg [At week 68]
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Waist Circumference [Baseline (week 0) to week 68]
Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Body Weight (Kg) [Baseline (week 0) to week 68]
Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in BMI [Baseline (week 0) to week 68]
Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% [At week 68]
Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% [At week 68]
Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% [At week 68]
Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in HbA1c (%) [Baseline (week 0) to week 68]
Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in HbA1c (mmol/Mol) [Baseline (week 0) to week 68]
Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in FPG (mg/dL) [Baseline (week 0) to week 68]
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Fasting Serum Insulin [Baseline (week 0) to week 68]
Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) [At week 68]
Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) [At week 68]
Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% [At week 68]
Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% [At week 68]
Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Systolic Blood Pressure [Baseline (week 0) to week 68]
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Diastolic Blood Pressure [Baseline (week 0) to week 68]
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Total Cholesterol [Baseline (week 0) to week 68]
Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in HDL Cholesterol [Baseline (week 0) to week 68]
Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in LDL Cholesterol [Baseline (week 0) to week 68]
Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in VLDL Cholesterol [Baseline (week 0) to week 68]
Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Free Fatty Acids [Baseline (week 0) to week 68]
Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Triglycerides [Baseline (week 0) to week 68]
Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in hsCRP [Baseline (week 0) to week 68]
Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in PAI-1 Activity [Baseline (week 0) to week 68]
Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) [Baseline (week 0) to week 68]
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
- Change in SF-36 (All Scores Except Physical Functioning) [Baseline (week 0) to week 68]
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
- Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) [Baseline (week 0) to week 68]
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Change in IWQOL-Lite for CT (All Scores Except Physical Function) [Baseline (week 0) to week 68]
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
- Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score [At week 68]
The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
- Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score [At week 68]
The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
- Number of TEAEs - Semaglutide 2.4 mg Versus Placebo [Week 0 to week 75]
Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
- Number of SAEs - Semaglutide 2.4 mg Versus Placebo [Week 0 to week 75]
Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
- Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo [Week 0 to week 75]
Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
- Change in Pulse - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
- Change in Amylase - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
- Change in Lipase - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
- Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, age greater than or equal to 18 years at the time of signing informed consent
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Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '
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History of at least one self-reported unsuccessful dietary effort to lose body weight
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Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening
Exclusion Criteria:
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A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
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Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m2 (less than 60 ml/min/1.73 m2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
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Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Novo Nordisk Investigational Site | Buena Park | California | United States | 90620 |
2 | Novo Nordisk Investigational Site | Concord | California | United States | 94520 |
3 | Novo Nordisk Investigational Site | Fresno | California | United States | 93720 |
4 | Novo Nordisk Investigational Site | Lomita | California | United States | 90717 |
5 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90057 |
6 | Novo Nordisk Investigational Site | Mission Hills | California | United States | 91345 |
7 | Novo Nordisk Investigational Site | Spring Valley | California | United States | 91978 |
8 | Novo Nordisk Investigational Site | Tarzana | California | United States | 91356-3551 |
9 | Novo Nordisk Investigational Site | Golden | Colorado | United States | 80401 |
10 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33765 |
11 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32205 |
12 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32216 |
13 | Novo Nordisk Investigational Site | Kissimmee | Florida | United States | 34744 |
14 | Novo Nordisk Investigational Site | Saint Petersburg | Florida | United States | 33709 |
15 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33606 |
16 | Novo Nordisk Investigational Site | Alpharetta | Georgia | United States | 30022 |
17 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30318 |
18 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
19 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
20 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60611 |
21 | Novo Nordisk Investigational Site | Springfield | Illinois | United States | 62711 |
22 | Novo Nordisk Investigational Site | West Des Moines | Iowa | United States | 50265 |
23 | Novo Nordisk Investigational Site | Topeka | Kansas | United States | 66606 |
24 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
25 | Novo Nordisk Investigational Site | Louisville | Kentucky | United States | 40213 |
26 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55416 |
27 | Novo Nordisk Investigational Site | Olive Branch | Mississippi | United States | 38654-3573 |
28 | Novo Nordisk Investigational Site | Butte | Montana | United States | 59701 |
29 | Novo Nordisk Investigational Site | Lawrenceville | New Jersey | United States | 08648 |
30 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27514 |
31 | Novo Nordisk Investigational Site | Greensboro | North Carolina | United States | 27408 |
32 | Novo Nordisk Investigational Site | Greenville | North Carolina | United States | 27834 |
33 | Novo Nordisk Investigational Site | Hickory | North Carolina | United States | 28601 |
34 | Novo Nordisk Investigational Site | Salisbury | North Carolina | United States | 28144 |
35 | Novo Nordisk Investigational Site | Wilmington | North Carolina | United States | 28401 |
36 | Novo Nordisk Investigational Site | Wadsworth | Ohio | United States | 44281 |
37 | Novo Nordisk Investigational Site | Anderson | South Carolina | United States | 29621 |
38 | Novo Nordisk Investigational Site | Mount Pleasant | South Carolina | United States | 29464 |
39 | Novo Nordisk Investigational Site | Bristol | Tennessee | United States | 37620 |
40 | Novo Nordisk Investigational Site | Nashville | Tennessee | United States | 37212 |
41 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78749 |
42 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
43 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
44 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75251 |
45 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75390-9302 |
46 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77079 |
47 | Novo Nordisk Investigational Site | Shavano Park | Texas | United States | 78231 |
48 | Novo Nordisk Investigational Site | Saint George | Utah | United States | 84790 |
49 | Novo Nordisk Investigational Site | Winchester | Virginia | United States | 22601 |
50 | Novo Nordisk Investigational Site | Olympia | Washington | United States | 98502 |
51 | Novo Nordisk Investigational Site | Caba | Argentina | C1060ABA | |
52 | Novo Nordisk Investigational Site | Chacabuco | Argentina | B6740ELF | |
53 | Novo Nordisk Investigational Site | Córdoba | Argentina | X5016KEH | |
54 | Novo Nordisk Investigational Site | Mendoza | Argentina | 5500 | |
55 | Novo Nordisk Investigational Site | Santiago del Estero | Argentina | G4200 | |
56 | Novo Nordisk Investigational Site | Calgary | Alberta | Canada | T2V 4J2 |
57 | Novo Nordisk Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada | A1N 1W7 |
58 | Novo Nordisk Investigational Site | Concord | Ontario | Canada | L4K 4M2 |
59 | Novo Nordisk Investigational Site | London | Ontario | Canada | N5W 6A2 |
60 | Novo Nordisk Investigational Site | Stoney Creek | Ontario | Canada | L8J 0B6 |
61 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4G 3E8 |
62 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M9V 4B4 |
63 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H1M 1B1 |
64 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4T 1Z9 |
65 | Novo Nordisk Investigational Site | St-Marc-des-Carrières | Quebec | Canada | G0A 4B0 |
66 | Novo Nordisk Investigational Site | Essen | Germany | 45136 | |
67 | Novo Nordisk Investigational Site | Falkensee | Germany | 14612 | |
68 | Novo Nordisk Investigational Site | Hamburg | Germany | 22041 | |
69 | Novo Nordisk Investigational Site | Hamburg | Germany | 22607 | |
70 | Novo Nordisk Investigational Site | Lingen | Germany | 49808 | |
71 | Novo Nordisk Investigational Site | Münster | Germany | 48145 | |
72 | Novo Nordisk Investigational Site | Rehlingen-Siersburg | Germany | 66780 | |
73 | Novo Nordisk Investigational Site | Schweinfurt | Germany | 97421 | |
74 | Novo Nordisk Investigational Site | Stuttgart | Germany | 70378 | |
75 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
76 | Novo Nordisk Investigational Site | Haidari-Athens | Greece | GR-12462 | |
77 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54636 | |
78 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54643 | |
79 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57001 | |
80 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57010 | |
81 | Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India | 380007 |
82 | Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India | 380054 |
83 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560054 |
84 | Novo Nordisk Investigational Site | Kochi | Kerala | India | 682041 |
85 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400008 |
86 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400012 |
87 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411013 |
88 | Novo Nordisk Investigational Site | New Dehli | New Delhi | India | 110029 |
89 | Novo Nordisk Investigational Site | Jaipur | Rajasthan | India | 302017 |
90 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600 013 |
91 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600086 |
92 | Novo Nordisk Investigational Site | Coimbatore | Tamil Nadu | India | 641009 |
93 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700054 |
94 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700064 |
95 | Novo Nordisk Investigational Site | New Delhi | India | 110088 | |
96 | Novo Nordisk Investigational Site | Secunderabad | India | 500 003 | |
97 | Novo Nordisk Investigational Site | Chiba-shi, Chiba | Japan | 260-0804 | |
98 | Novo Nordisk Investigational Site | Chuo-ku, Tokyo | Japan | 103-0002 | |
99 | Novo Nordisk Investigational Site | Fukuoka-shi, Fukuoka | Japan | 812-8582 | |
100 | Novo Nordisk Investigational Site | Hokkaido | Japan | 060-0062 | |
101 | Novo Nordisk Investigational Site | Hokkaido | Japan | 062-0007 | |
102 | Novo Nordisk Investigational Site | Ibaraki | Japan | 311-0113 | |
103 | Novo Nordisk Investigational Site | Kashiwara-shi, Osaka | Japan | 582-0005 | |
104 | Novo Nordisk Investigational Site | Mitaka-shi, Tokyo | Japan | 181-0013 | |
105 | Novo Nordisk Investigational Site | Osaka | Japan | 565-0871 | |
106 | Novo Nordisk Investigational Site | Osaka | Japan | 569-1045 | |
107 | Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | Japan | 060-0001 | |
108 | Novo Nordisk Investigational Site | Tochigi | Japan | 323-0022 | |
109 | Novo Nordisk Investigational Site | San Juan | Puerto Rico | 00921 | |
110 | Novo Nordisk Investigational Site | Barnaul | Russian Federation | 656043 | |
111 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 117036 | |
112 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 123448 | |
113 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 127486 | |
114 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 129110 | |
115 | Novo Nordisk Investigational Site | Saint Petersburg | Russian Federation | 194291 | |
116 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194354 | |
117 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 199226 | |
118 | Novo Nordisk Investigational Site | Tomsk | Russian Federation | 634050 | |
119 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2001 |
120 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2013 |
121 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0181 |
122 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0184 |
123 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4001 |
124 | Novo Nordisk Investigational Site | Brits | North West | South Africa | 0250 |
125 | Novo Nordisk Investigational Site | Almeria | Spain | 04009 | |
126 | Novo Nordisk Investigational Site | Córdoba | Spain | 14004 | |
127 | Novo Nordisk Investigational Site | Madrid | Spain | 28040 | |
128 | Novo Nordisk Investigational Site | Málaga | Spain | 29010 | |
129 | Novo Nordisk Investigational Site | San Cristóbal de La Laguna | Spain | 38320 | |
130 | Novo Nordisk Investigational Site | Sevilla | Spain | 41003 | |
131 | Novo Nordisk Investigational Site | Sevilla | Spain | 41010 | |
132 | Novo Nordisk Investigational Site | Valladolid | Spain | 47010 | |
133 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates | 22241 | |
134 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates | 4545 | |
135 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates | 9115 | |
136 | Novo Nordisk Investigational Site | Hatta | United Arab Emirates | 7272 | |
137 | Novo Nordisk Investigational Site | Umm Al Quwain | United Arab Emirates | 24 | |
138 | Novo Nordisk Investigational Site | Chester | United Kingdom | CH2 1UL | |
139 | Novo Nordisk Investigational Site | Crewe | United Kingdom | CW5 5NX | |
140 | Novo Nordisk Investigational Site | Glasgow | United Kingdom | G31 2ER | |
141 | Novo Nordisk Investigational Site | Harrogate, North Yorkshire | United Kingdom | HG2 7SX | |
142 | Novo Nordisk Investigational Site | Leicester | United Kingdom | LE5 4PW | |
143 | Novo Nordisk Investigational Site | Middlesbrough | United Kingdom | TS4 3BW | |
144 | Novo Nordisk Investigational Site | Soham | United Kingdom | CB7 5JD | |
145 | Novo Nordisk Investigational Site | Stevenage | United Kingdom | SG1 4AB | |
146 | Novo Nordisk Investigational Site | Watford | United Kingdom | WD25 7NL | |
147 | Novo Nordisk Investigational Site | Wellingborough | United Kingdom | NN8 4RW |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
More Information
Publications
- NN9536-4374
- U1111-1200-8148
- 2017-003414-10
Study Results
Participant Flow
Recruitment Details | The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites). |
---|---|
Pre-assignment Detail | Participants were randomised in 1:1:1 ratio to receive either 'semaglutide 2.4 milligram (mg) and placebo II (placebo matched to semaglutide 1.0 mg) once weekly', 'semaglutide 1.0 mg and placebo I (placebo matched to semaglutide 2.4 mg) once weekly' or 'placebo I and placebo II once weekly'. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Period Title: Overall Study | |||
STARTED | 403 | 404 | 403 |
Exposed | 402 | 403 | 402 |
Full Analysis Set (FAS) | 403 | 404 | 403 |
Safety Analysis Set (SAS) | 402 | 403 | 402 |
COMPLETED | 390 | 391 | 383 |
NOT COMPLETED | 13 | 13 | 20 |
Baseline Characteristics
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | Total |
---|---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Total of all reporting groups |
Overall Participants | 403 | 404 | 403 | 1210 |
Age (Year) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Year] |
56
(10)
|
55
(11)
|
55
(11)
|
55
(11)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
203
50.4%
|
223
55.2%
|
190
47.1%
|
616
50.9%
|
Male |
200
49.6%
|
181
44.8%
|
213
52.9%
|
594
49.1%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
272
67.5%
|
237
58.7%
|
242
60%
|
751
62.1%
|
Asian |
97
24.1%
|
112
27.7%
|
108
26.8%
|
317
26.2%
|
Black or African American |
28
6.9%
|
35
8.7%
|
37
9.2%
|
100
8.3%
|
Other |
6
1.5%
|
16
4%
|
13
3.2%
|
35
2.9%
|
American Indian or Alaska Native |
0
0%
|
4
1%
|
2
0.5%
|
6
0.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
0.2%
|
1
0.1%
|
Not Applicable |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
Not Hispanic or Latino |
344
85.4%
|
357
88.4%
|
354
87.8%
|
1055
87.2%
|
Hispanic or Latino |
59
14.6%
|
47
11.6%
|
49
12.2%
|
155
12.8%
|
Not Applicable |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 404 | 403 |
In-trial observation period |
-9.9
(8.0)
|
-3.3
(5.5)
|
On-treatment observation period |
-10.7
(7.8)
|
-3.1
(5.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 2.4 mg, Placebo |
---|---|---|
Comments | Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Treatment difference |
Estimated Value | -6.21 | |
Confidence Interval |
(2-Sided) 95% -7.28 to -5.15 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 2.4 mg, Placebo |
---|---|---|
Comments | Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Treatment difference |
Estimated Value | -7.57 | |
Confidence Interval |
(2-Sided) 95% -8.56 to -6.58 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 404 | 403 |
Yes |
267
66.3%
|
107
26.5%
|
No |
121
30%
|
269
66.6%
|
Yes |
257
63.8%
|
94
23.3%
|
No |
94
23.3%
|
246
60.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 2.4 mg, Placebo |
---|---|---|
Comments | Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 4.88 | |
Confidence Interval |
(2-Sided) 95% 3.58 to 6.64 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 2.4 mg, Placebo |
---|---|---|
Comments | Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 8.69 | |
Confidence Interval |
(2-Sided) 95% 6.31 to 11.97 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg |
---|---|
Description | Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Semaglutide 1.0 mg |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 388 | 380 |
Mean (Standard Deviation) [Percentage point of body weight] |
-9.9
(8.0)
|
-7.2
(6.6)
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg |
---|---|
Description | Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Semaglutide 1.0 mg |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 388 | 380 |
Yes |
267
66.3%
|
217
53.7%
|
No |
121
30%
|
163
40.3%
|
Title | Change in Waist Circumference |
---|---|
Description | Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 387 | 375 |
Mean (Standard Deviation) [Centimetre (cm)] |
-6.9
(6.8)
|
-9.7
(8.1)
|
-4.3
(6.5)
|
Title | Change in Body Weight (Kg) |
---|---|
Description | Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 388 | 376 |
Mean (Standard Deviation) [Kilogram (kg)] |
-7.1
(6.7)
|
-9.9
(8.5)
|
-3.4
(6.2)
|
Title | Change in BMI |
---|---|
Description | Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 388 | 376 |
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
-2.6
(2.4)
|
-3.6
(3.1)
|
-1.2
(2.1)
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% |
---|---|
Description | Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 388 | 376 |
Yes |
109
27%
|
177
43.8%
|
31
7.7%
|
No |
271
67.2%
|
211
52.2%
|
345
85.6%
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% |
---|---|
Description | Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 388 | 376 |
Yes |
52
12.9%
|
100
24.8%
|
12
3%
|
No |
328
81.4%
|
288
71.3%
|
364
90.3%
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% |
---|---|
Description | Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 380 | 388 | 376 |
Yes |
18
4.5%
|
51
12.6%
|
6
1.5%
|
No |
362
89.8%
|
337
83.4%
|
370
91.8%
|
Title | Change in HbA1c (%) |
---|---|
Description | Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Mean (Standard Deviation) [Percentage point of HbA1c] |
-1.5
(1.1)
|
-1.7
(1.2)
|
-0.3
(1.3)
|
Title | Change in HbA1c (mmol/Mol) |
---|---|
Description | Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Mean (Standard Deviation) [millimoles per mole (mmol/mol)] |
-16.9
(12.3)
|
-18.7
(13.0)
|
-3.4
(14.3)
|
Title | Change in FPG (mg/dL) |
---|---|
Description | Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 367 | 375 | 370 |
Mean (Standard Deviation) [milligrams per deciliter (mg/dL)] |
-36.5
(45.1)
|
-37.9
(45.9)
|
-2.3
(53.1)
|
Title | Change in Fasting Serum Insulin |
---|---|
Description | Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 352 | 360 | 351 |
Geometric Mean (Geometric Coefficient of Variation) [Picomoles per litre (pmol/L)] |
0.94
(59.8)
|
0.90
(65.4)
|
0.93
(53.6)
|
Title | Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) |
---|---|
Description | Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Yes |
272
67.5%
|
299
74%
|
99
24.6%
|
No |
104
25.8%
|
82
20.3%
|
275
68.2%
|
Title | Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) |
---|---|
Description | Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Yes |
226
56.1%
|
257
63.6%
|
58
14.4%
|
No |
150
37.2%
|
124
30.7%
|
316
78.4%
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% |
---|---|
Description | Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Yes |
105
26.1%
|
170
42.1%
|
25
6.2%
|
No |
271
67.2%
|
211
52.2%
|
349
86.6%
|
Title | Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% |
---|---|
Description | Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 376 | 381 | 374 |
Yes |
49
12.2%
|
98
24.3%
|
11
2.7%
|
No |
327
81.1%
|
283
70%
|
363
90.1%
|
Title | Change in Systolic Blood Pressure |
---|---|
Description | Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 379 | 387 | 376 |
Mean (Standard Deviation) [Millimetre of mercury (mmHg)] |
-3
(15)
|
-4
(14)
|
0
(15)
|
Title | Change in Diastolic Blood Pressure |
---|---|
Description | Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 379 | 387 | 376 |
Mean (Standard Deviation) [Millimetre of mercury (mmHg)] |
-1
(9)
|
-2
(9)
|
-1
(9)
|
Title | Change in Total Cholesterol |
---|---|
Description | Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 380 | 373 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total cholesterol] |
0.97
(20.1)
|
0.99
(17.9)
|
1.00
(18.9)
|
Title | Change in HDL Cholesterol |
---|---|
Description | Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 375 | 369 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of HDL cholesterol] |
1.06
(16.0)
|
1.07
(15.7)
|
1.04
(15.3)
|
Title | Change in LDL Cholesterol |
---|---|
Description | Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 380 | 373 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of LDL cholesterol] |
0.99
(37.5)
|
1.00
(30.9)
|
1.00
(28.9)
|
Title | Change in VLDL Cholesterol |
---|---|
Description | Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 380 | 373 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of VLDL cholesterol] |
0.82
(42.1)
|
0.80
(42.0)
|
0.92
(40.5)
|
Title | Change in Free Fatty Acids |
---|---|
Description | Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 353 | 361 | 354 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of free fatty acids] |
0.85
(61.4)
|
0.84
(68.7)
|
1.01
(62.3)
|
Title | Change in Triglycerides |
---|---|
Description | Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 380 | 373 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of triglycerides] |
0.81
(44.5)
|
0.79
(43.8)
|
0.92
(44.5)
|
Title | Change in hsCRP |
---|---|
Description | Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 372 | 380 | 373 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of hsCRP] |
0.59
(115.7)
|
0.50
(125.7)
|
0.84
(90.9)
|
Title | Change in PAI-1 Activity |
---|---|
Description | Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 334 | 353 | 336 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of PAI-1 activity] |
1.21
(73.7)
|
1.06
(80.8)
|
1.42
(68.9)
|
Title | Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) |
---|---|
Description | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 370 | 376 | 365 |
Mean (Standard Deviation) [Score on a scale] |
2.1
(6.8)
|
2.8
(7.7)
|
0.8
(7.0)
|
Title | Change in SF-36 (All Scores Except Physical Functioning) |
---|---|
Description | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 370 | 376 | 365 |
Role-Physical |
0.6
(6.9)
|
0.8
(7.4)
|
0.0
(7.1)
|
Bodily Pain |
0.4
(8.3)
|
0.3
(9.0)
|
-0.4
(8.6)
|
General Health |
1.7
(7.2)
|
2.2
(7.3)
|
0.6
(7.5)
|
Vitality |
-0.1
(7.8)
|
0.8
(7.9)
|
-0.9
(7.9)
|
Social Functioning |
-0.3
(6.6)
|
0.2
(6.6)
|
-0.7
(7.4)
|
Role-Emotional |
-0.4
(7.3)
|
-0.4
(7.7)
|
-1.1
(7.8)
|
Mental Health |
-0.9
(7.5)
|
-0.4
(6.9)
|
-1.6
(7.5)
|
Physical component summary |
1.9
(6.4)
|
2.3
(7.2)
|
0.9
(6.6)
|
Mental component summary |
-1.4
(7.4)
|
-0.9
(6.9)
|
-1.8
(7.6)
|
Title | Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) |
---|---|
Description | The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 369 | 376 | 365 |
Mean (Standard Deviation) [Score on a scale] |
8.5
(18.8)
|
11.4
(20.8)
|
4.9
(20.4)
|
Title | Change in IWQOL-Lite for CT (All Scores Except Physical Function) |
---|---|
Description | The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 369 | 376 | 365 |
Physical |
7.6
(18.0)
|
11.0
(19.6)
|
4.4
(19.1)
|
Psychosocial |
8.6
(15.7)
|
9.6
(16.7)
|
5.6
(16.5)
|
Total |
8.2
(14.8)
|
10.1
(15.9)
|
5.2
(15.5)
|
Title | Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score |
---|---|
Description | The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 370 | 376 | 365 |
Yes (with threshold 4.3) |
88
21.8%
|
111
27.5%
|
68
16.9%
|
No (with threshold 4.3) |
282
70%
|
265
65.6%
|
297
73.7%
|
Yes (with threshold 3.7) |
130
32.3%
|
158
39.1%
|
102
25.3%
|
No (with threshold 3.7) |
240
59.6%
|
218
54%
|
263
65.3%
|
Title | Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score |
---|---|
Description | The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). |
Time Frame | At week 68 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 369 | 376 | 365 |
Yes (with threshold 20) |
107
26.6%
|
131
32.4%
|
83
20.6%
|
No (with threshold 20) |
262
65%
|
245
60.6%
|
282
70%
|
Yes (with threshold 14.6) |
144
35.7%
|
160
39.6%
|
113
28%
|
No (with threshold 14.6) |
225
55.8%
|
216
53.5%
|
252
62.5%
|
Title | Number of TEAEs - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses. |
Time Frame | Week 0 to week 75 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 403 | 402 |
Number [Events] |
2197
|
1388
|
Title | Number of SAEs - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses. |
Time Frame | Week 0 to week 75 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 403 | 402 |
Number [Events] |
71
|
53
|
Title | Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
Time Frame | Week 0 to week 75 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 403 | 402 |
Number [Episodes] |
51
|
18
|
Title | Change in Pulse - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 351 | 340 |
Mean (Standard Deviation) [Beats/minute] |
2
(9)
|
0
(9)
|
Title | Change in Amylase - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 350 | 338 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of amylase] |
1.24
(28.3)
|
1.06
(25.0)
|
Title | Change in Lipase - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 350 | 338 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of lipase] |
1.41
(57.2)
|
0.99
(51.8)
|
Title | Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo |
---|---|
Description | Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
Time Frame | Baseline (week 0) to week 68 |
Outcome Measure Data
Analysis Population Description |
---|
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. |
Measure Participants | 348 | 339 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio of calcitonin] |
0.94
(60.3)
|
0.96
(38.6)
|
Adverse Events
Time Frame | Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | All presented AEs are treatment-emergent (i.e., TEAEs). | |||||
Arm/Group Title | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | |||
Arm/Group Description | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. | |||
All Cause Mortality |
||||||
Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/402 (0.2%) | 1/403 (0.2%) | 1/402 (0.2%) | |||
Serious Adverse Events |
||||||
Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 31/402 (7.7%) | 40/403 (9.9%) | 37/402 (9.2%) | |||
Cardiac disorders | ||||||
Acute myocardial infarction | 2/402 (0.5%) | 2 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Angina pectoris | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Angina unstable | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Atrial fibrillation | 2/402 (0.5%) | 2 | 2/403 (0.5%) | 2 | 2/402 (0.5%) | 2 |
Bradycardia | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Cardiac failure acute | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Cardiac failure congestive | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Myocardial infarction | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Myocardial ischaemia | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Supraventricular tachycardia | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Eye disorders | ||||||
Cataract | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Glaucoma | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Gastrointestinal disorders | ||||||
Abdominal pain | 3/402 (0.7%) | 3 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Diarrhoea | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Diverticular perforation | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Food poisoning | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Gastric ulcer | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Gastritis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Inguinal hernia | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Nausea | 2/402 (0.5%) | 2 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Obstructive pancreatitis | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Small intestinal obstruction | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Upper gastrointestinal haemorrhage | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Vomiting | 0/402 (0%) | 0 | 2/403 (0.5%) | 2 | 0/402 (0%) | 0 |
General disorders | ||||||
Chest pain | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Hepatobiliary disorders | ||||||
Cholecystitis acute | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Cholecystitis chronic | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Cholelithiasis | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Non-alcoholic steatohepatitis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Immune system disorders | ||||||
Immunisation reaction | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Infections and infestations | ||||||
Appendicitis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Bronchitis | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Cellulitis | 2/402 (0.5%) | 2 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Colonic abscess | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Cystitis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Diverticulitis | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Empyema | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Gastroenteritis | 3/402 (0.7%) | 3 | 3/403 (0.7%) | 3 | 1/402 (0.2%) | 1 |
Herpes zoster | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Joint abscess | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Kidney infection | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Osteomyelitis | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Pharyngitis streptococcal | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Pneumonia | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 2/402 (0.5%) | 2 |
Pneumonia influenzal | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Postoperative wound infection | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Respiratory tract infection | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Sepsis | 3/402 (0.7%) | 3 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Urosepsis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Viral infection | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Wound infection staphylococcal | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Injury, poisoning and procedural complications | ||||||
Anaemia postoperative | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Ankle fracture | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Cervical vertebral fracture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Fall | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Hip fracture | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Humerus fracture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Joint dislocation | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Ligament rupture | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Lisfranc fracture | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Post procedural haemorrhage | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Rib fracture | 0/402 (0%) | 0 | 2/403 (0.5%) | 2 | 0/402 (0%) | 0 |
Road traffic accident | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Skin laceration | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Spinal compression fracture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Subdural haematoma | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Thoracic vertebral fracture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Traumatic haemothorax | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Upper limb fracture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Metabolism and nutrition disorders | ||||||
Cachexia | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Decreased appetite | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Dehydration | 2/402 (0.5%) | 2 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Diabetes mellitus inadequate control | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Diabetic ketoacidosis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Diabetic metabolic decompensation | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Hyperglycaemia | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Hyponatraemia | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Ketoacidosis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Lactic acidosis | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Obesity | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||
Neuropathic arthropathy | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Osteoarthritis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Pain in extremity | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Rotator cuff syndrome | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Spondylolisthesis | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Trigger finger | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Adenocarcinoma gastric | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Adenocarcinoma of colon | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Gastric cancer | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Gastric cancer stage IV | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Gastrointestinal lymphoma | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Gastrointestinal stromal tumour | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Hepatocellular carcinoma | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Invasive ductal breast carcinoma | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Keratinising squamous cell carcinoma of nasopharynx | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Myeloid leukaemia | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Neuroendocrine tumour | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Prostate cancer | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 2/402 (0.5%) | 2 |
Uterine cancer | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Nervous system disorders | ||||||
Cerebral artery thrombosis | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Cerebral infarction | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Cerebrovascular accident | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Hepatic encephalopathy | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Hyperaesthesia | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Hyponatraemic encephalopathy | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Ischaemic stroke | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Presyncope | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Spinal epidural haematoma | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Subarachnoid haemorrhage | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Syncope | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Pregnancy, puerperium and perinatal conditions | ||||||
Abortion spontaneous | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Renal and urinary disorders | ||||||
Acute kidney injury | 2/402 (0.5%) | 2 | 2/403 (0.5%) | 3 | 1/402 (0.2%) | 1 |
Bladder outlet obstruction | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Stag horn calculus | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Ureterolithiasis | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 2/402 (0.5%) | 2 |
Reproductive system and breast disorders | ||||||
Uterine polyp | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Acute respiratory failure | 1/402 (0.2%) | 1 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Asthma | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 1/402 (0.2%) | 1 |
Pneumothorax | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Surgical and medical procedures | ||||||
Cardiac pacemaker replacement | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Sperm aspiration | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Stent placement | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Thyroidectomy | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Vascular disorders | ||||||
Aortic rupture | 0/402 (0%) | 0 | 1/403 (0.2%) | 1 | 0/402 (0%) | 0 |
Hypertension | 0/402 (0%) | 0 | 2/403 (0.5%) | 2 | 0/402 (0%) | 0 |
Hypertensive urgency | 0/402 (0%) | 0 | 0/403 (0%) | 0 | 1/402 (0.2%) | 1 |
Shock | 1/402 (0.2%) | 1 | 0/403 (0%) | 0 | 0/402 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 261/402 (64.9%) | 284/403 (70.5%) | 190/402 (47.3%) | |||
Gastrointestinal disorders | ||||||
Abdominal distension | 9/402 (2.2%) | 12 | 24/403 (6%) | 30 | 11/402 (2.7%) | 13 |
Constipation | 51/402 (12.7%) | 70 | 70/403 (17.4%) | 82 | 22/402 (5.5%) | 26 |
Diarrhoea | 88/402 (21.9%) | 157 | 86/403 (21.3%) | 141 | 48/402 (11.9%) | 66 |
Dyspepsia | 27/402 (6.7%) | 27 | 25/403 (6.2%) | 30 | 5/402 (1.2%) | 5 |
Flatulence | 21/402 (5.2%) | 25 | 16/403 (4%) | 21 | 7/402 (1.7%) | 9 |
Nausea | 128/402 (31.8%) | 196 | 135/403 (33.5%) | 248 | 37/402 (9.2%) | 45 |
Vomiting | 54/402 (13.4%) | 93 | 86/403 (21.3%) | 186 | 11/402 (2.7%) | 12 |
General disorders | ||||||
Fatigue | 19/402 (4.7%) | 26 | 28/403 (6.9%) | 29 | 4/402 (1%) | 4 |
Infections and infestations | ||||||
Gastroenteritis | 21/402 (5.2%) | 25 | 11/403 (2.7%) | 12 | 12/402 (3%) | 14 |
Nasopharyngitis | 47/402 (11.7%) | 69 | 68/403 (16.9%) | 115 | 59/402 (14.7%) | 92 |
Upper respiratory tract infection | 37/402 (9.2%) | 54 | 42/403 (10.4%) | 48 | 38/402 (9.5%) | 50 |
Metabolism and nutrition disorders | ||||||
Decreased appetite | 29/402 (7.2%) | 33 | 38/403 (9.4%) | 41 | 15/402 (3.7%) | 17 |
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 24/402 (6%) | 27 | 23/403 (5.7%) | 29 | 20/402 (5%) | 20 |
Back pain | 28/402 (7%) | 30 | 27/403 (6.7%) | 30 | 14/402 (3.5%) | 15 |
Nervous system disorders | ||||||
Headache | 33/402 (8.2%) | 48 | 31/403 (7.7%) | 40 | 20/402 (5%) | 27 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Clinical Transparency Anchor and Disclosure (1452) |
---|---|
Organization | Novo Nordisk A/S |
Phone | (+1) 866-867-7178 |
clinicaltrials@novonordisk.com |
- NN9536-4374
- U1111-1200-8148
- 2017-003414-10