Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03856047
• Collaborator: (none)
• Enrollment: 706
• Locations: 54
• Arms: 12
• Actual Duration (Months): 24.8
• Patients Per Site: 13.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. 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 8 months. Participants will have 12 clinic visits with the study doctor.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Drug: NNC0174-0833; Drug: Placebo (NNC0174-0833); Drug: Liraglutide 3.0 mg; Drug: Placebo (Liraglutide 3.0 mg)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 706 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• Official Title: Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Mar 2, 2020
• Actual Study Completion Date: Mar 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0174-0833, 4.5 mg Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: NNC0174-0833; Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Experimental: NNC0174-0833, 2.4 mg Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: NNC0174-0833; Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Experimental: NNC0174-0833, 1.2 mg Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: NNC0174-0833; Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Experimental: NNC0174-0833, 0.6 mg Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: NNC0174-0833; Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Experimental: NNC0174-0833 0.3 mg Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: NNC0174-0833; Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo Comparator: Placebo 2.4 mg (NNC0174-0833) Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	Drug: Placebo (NNC0174-0833); Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo Comparator: Placebo 4.5 mg (NNC0174-0833) Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	Drug: Placebo (NNC0174-0833); Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo Comparator: Placebo 1.2 mg (NNC0174-0833) Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	Drug: Placebo (NNC0174-0833); Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo Comparator: Placebo 0.6 mg (NNC0174-0833) Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	Drug: Placebo (NNC0174-0833); Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo Comparator: Placebo 0.3 mg (NNC0174-0833) Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: Placebo (NNC0174-0833); Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Active Comparator: Liraglutide 3.0 mg Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.	Drug: Liraglutide 3.0 mg; Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
Placebo Comparator: Placebo 3.0 mg (Liraglutide) Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.	Drug: Placebo (Liraglutide 3.0 mg); Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.

Outcome Measures

Primary Outcome Measures

1. Change in body weight [Week 0, Week 26]

   Percent

Secondary Outcome Measures

1. Subjects who achieve 5 percent or more body weight reduction (yes/no) [Week 26]

   Percentage of subjects

2. Subjects who achieve 10 percent or more body weight reduction (yes/no) [Week 26]

   Percentage of subjects

3. Change in body weight (kg) [Week 0, Week 26]

   Measured in kilograms

4. Change in waist circumference (cm) [Week 0, Week 26]

   Measured in centimeters

5. Change in fasting lipids - total cholesterol [Week 0, Week 26]

   Measured in mg/dL

6. Change in fasting lipids - high density lipoprotein (HDL) cholesterol [Week 0, Week 26]

   Measured in mg/dL

7. Change in fasting lipids - low density lipoprotein (LDL) cholesterol [Week 0, Week 26]

   Measured in mg/dL

8. Change in fasting lipids - very low density lipoprotein (VLDL) cholesterol [Week 0, Week 26]

   Measured in mg/dL

9. Change in fasting lipids - triglycerides [Week 0, Week 26]

   Measured in mg/dL

10. Change in glycosylated haemoglobin (HbA1c) [Week 0, Week 26]

    Measured in percentage-points

11. Change in fasting plasma glucose (FPG) [Week 0, Week 26]

    Measured in mg/dL

12. Change in fasting insulin. [Week 0, Week 26]

    Measured in μIU/mL

13. Change in Homeostatic model assessment of insulin resistance (HOMA-IR) [Week 0, Week 26]

    Measured in percentage-points

14. Change in Homeostatic model assessment of β-cell function (HOMA-β) [Week 0, Week 26]

    Measured in percentage-points

15. Number of treatment emergent adverse events (TEAEs) from randomisation to end of trial [Week 0-32]

    Measured in number of participants

16. Number of treatment emergent serious adverse events (SAEs) [Week 0-32]

    Measured in number of participants

17. Occurrence of anti-drug antibodies towards NNC0174-0833 (yes/no) [Week 0-32]

    Percentage of participants

18. Change in systolic blood pressure [Week 0, Week 26]

    Measured in mmHg

19. Change in diastolic blood pressure [Week 0, Week 26]

    Measured in mmHg

20. Change in mean 24-hour systolic blood pressure [Week 0, Week 26]

    Measured in mmHg

21. Change in mean 24-hour diastolic blood pressure [Week 0, Week 26]

    Measured in mmHg

22. Change in pulse [Week 0, Week 26]

    Measured in beats per minute

23. Change in high sensitivity C-Reactive Protein (hsCRP) [Week 0, Week 26]

    Measured in mg/L

24. Change in plasminogen activator inhibitor-1 (PAI-1) activity [Week 0, Week 26]

    Measured in mg/L

25. Change in renin activity [Week 0, Week 26]

    Measured in g/mL/h

26. Change in aldosterone [Week 0, Week 26]

    Measured in ng/dL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older at the time of signing the informed consent.

• Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').

• BMI equal to 30.0 kg/m^{2 or greater or BMI equal to 27.0 kg/m}2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

Exclusion Criteria:

• HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.

• A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Anaheim	California	United States	92801
2	Novo Nordisk Investigational Site	Spring Valley	California	United States	91978
3	Novo Nordisk Investigational Site	Crystal River	Florida	United States	34429
4	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
5	Novo Nordisk Investigational Site	Pembroke Pines	Florida	United States	33027
6	Novo Nordisk Investigational Site	Ponte Vedra	Florida	United States	32081
7	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
8	Novo Nordisk Investigational Site	Elkridge	Maryland	United States	21075-6437
9	Novo Nordisk Investigational Site	North Dartmouth	Massachusetts	United States	02747
10	Novo Nordisk Investigational Site	Rochester	New York	United States	14609
11	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
12	Novo Nordisk Investigational Site	Franklin	Ohio	United States	45005
13	Novo Nordisk Investigational Site	Mason	Ohio	United States	45040-6815
14	Novo Nordisk Investigational Site	Wadsworth	Ohio	United States	44281
15	Novo Nordisk Investigational Site	Norman	Oklahoma	United States	73069
16	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29425
17	Novo Nordisk Investigational Site	Gaffney	South Carolina	United States	29341
18	Novo Nordisk Investigational Site	Spartanburg	South Carolina	United States	29303
19	Novo Nordisk Investigational Site	Bristol	Tennessee	United States	37620-7352
20	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
21	Novo Nordisk Investigational Site	Arlington	Virginia	United States	22206
22	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23294
23	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2T 5C7
24	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2V 4J2
25	Novo Nordisk Investigational Site	Edmonton	Alberta	Canada	T6H 2L4
26	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
27	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
28	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
29	Novo Nordisk Investigational Site	Hvidovre		Denmark	2650
30	Novo Nordisk Investigational Site	Jyväskylä		Finland	40620
31	Novo Nordisk Investigational Site	Kuopio		Finland	70211
32	Novo Nordisk Investigational Site	Turku		Finland	20520
33	Novo Nordisk Investigational Site	University Of Helsinki		Finland	00014
34	Novo Nordisk Investigational Site	Dublin		Ireland	DUBLIN 4
35	Novo Nordisk Investigational Site	Tokyo		Japan	103-0027
36	Novo Nordisk Investigational Site	Tokyo		Japan	103-0028
37	Novo Nordisk Investigational Site	Tokyo		Japan	160-0008
38	Novo Nordisk Investigational Site	Bialystok		Poland	15-281
39	Novo Nordisk Investigational Site	Katowice		Poland	40-001
40	Novo Nordisk Investigational Site	Poznan		Poland	60-589
41	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
42	Novo Nordisk Investigational Site	Novi Sad		Serbia	21000
43	Novo Nordisk Investigational Site	Bloemfontein	Free State	South Africa	9300
44	Novo Nordisk Investigational Site	Boksburg	Gauteng	South Africa	1466
45	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1812
46	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4091
47	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4450
48	Novo Nordisk Investigational Site	Bradford-on-Avon		United Kingdom	BA15 1DQ
49	Novo Nordisk Investigational Site	Bristol		United Kingdom	BS10 5NB
50	Novo Nordisk Investigational Site	Coventry		United Kingdom	CV2 2DX
51	Novo Nordisk Investigational Site	Liverpool		United Kingdom	L9 7AL
52	Novo Nordisk Investigational Site	London		United Kingdom	SE1 9RT
53	Novo Nordisk Investigational Site	London		United Kingdom	WC1E 6JF
54	Novo Nordisk Investigational Site	Rotherham		United Kingdom	S65 1DA

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03856047
• Other Study ID Numbers: NN9838-4433; U1111-1214-0429; 2018-001945-14
• First Posted: Feb 27, 2019
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Overweight; Liraglutide

Study Results

No Results Posted as of Feb 28, 2022