Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05064735

Collaborator

(none)

375

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: semaglutide 2.4 mg Drug: semaglutide 2.4 mg (placebo)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Apr 25, 2023

Anticipated Study Completion Date :

Sep 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: semaglutide 2.4 mg Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity	Drug: semaglutide 2.4 mg semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
Placebo Comparator: semaglutide 2.4 mg (placebo) Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity	Drug: semaglutide 2.4 mg (placebo) semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Arm

Intervention/Treatment

Experimental: semaglutide 2.4 mg

Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Drug: semaglutide 2.4 mg

semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Placebo Comparator: semaglutide 2.4 mg (placebo)

Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Drug: semaglutide 2.4 mg (placebo)

semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Outcome Measures

Primary Outcome Measures

Change in body weight [From baseline (week 0) to end of treatment (week 68)]
Percentage
Change in WOMAC pain score [From baseline (week 0) to end of treatment (week 68)]
Score points

Secondary Outcome Measures

Achieving body weight reduction greater than or equal to 5% (yes/no) [From baseline (week 0) to end of treatment (week 68)]
Count of subjects
Achieving body weight reduction greater than or equal to 10% (yes/no) [From baseline (week 0) to end of treatment (week 68)]
Count of subjects
Change in WOMAC physical function score [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in SF-36 physical functioning score [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in waist circumference [From baseline (week 0) to end of treatment (week 68)]
cm
Change in WOMAC stiffness score [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in WOMAC total score [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in SF-36 bodily pain score [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in SF-36 physical component summary [From baseline (week 0) to end of treatment (week 68)]
Score points
Change in SF-36 mental component summary [From baseline (week 0) to end of treatment (week 68)]
Score points
Use of allowed rescue analgesics during wash out [From baseline (week 0) to end of treatment (week 68)]
Count of subjects
Amount of allowed rescue analgesics used during wash out [From baseline (week 0) to end of treatment (week 68)]
Dose
Change in pain medication [From baseline (week 0) to end of treatment (week 68)]
Dose
Change in pain intensity (NRS) [From baseline (week 0) to end of treatment (week 68)]
Score points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female, age above or equal to 18 years at the time of signing informed consent
Body Mass Index (BMI) equal to or greater than 30.0 kg/m^2
Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg.
Pain due to knee OA

Exclusion Criteria:

Joint replacement in target knee
Arthroscopy or injections into target knee within last 3 months prior to enrolment
Any other joint disease in the target knee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Montgomery	Alabama	United States	36106
2	Novo Nordisk Investigational Site	Palm Springs	California	United States	92262
3	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
4	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32205
5	Novo Nordisk Investigational Site	Ocala	Florida	United States	34470
6	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
7	Novo Nordisk Investigational Site	Evanston	Illinois	United States	60201-2477
8	Novo Nordisk Investigational Site	Gurnee	Illinois	United States	60031
9	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40213
10	Novo Nordisk Investigational Site	Troy	Michigan	United States	48098
11	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63141
12	Novo Nordisk Investigational Site	West Seneca	New York	United States	14224
13	Novo Nordisk Investigational Site	Westfield	New York	United States	14787
14	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
15	Novo Nordisk Investigational Site	Cleveland	Ohio	United States	44195
16	Novo Nordisk Investigational Site	Franklin	Ohio	United States	45005
17	Novo Nordisk Investigational Site	North Charleston	South Carolina	United States	29405
18	Novo Nordisk Investigational Site	Houston	Texas	United States	77024
19	Novo Nordisk Investigational Site	Newport News	Virginia	United States	23606
20	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
21	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
22	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
23	Novo Nordisk Investigational Site	London	Ontario	Canada	N5W 6A2
24	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M9V 4B4
25	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4N 2W2
26	Novo Nordisk Investigational Site	Barranquilla		Colombia	80020
27	Novo Nordisk Investigational Site	Bogota		Colombia	110221
28	Novo Nordisk Investigational Site	Chia		Colombia	250001
29	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
30	Novo Nordisk Investigational Site	Frederiksberg		Denmark	2000
31	Novo Nordisk Investigational Site	Clermont-Ferrand		France	63000
32	Novo Nordisk Investigational Site	PARIS cedex 13		France	75651
33	Novo Nordisk Investigational Site	Paris		France	75908
34	Novo Nordisk Investigational Site	Pierre Benite		France	69310
35	Novo Nordisk Investigational Site	TOULOUSE cedex		France	31054
36	Novo Nordisk Investigational Site	Nordbyhagen		Norway	1474
37	Novo Nordisk Investigational Site	Oslo		Norway	0586
38	Novo Nordisk Investigational Site	Tønsberg		Norway	3117
39	Novo Nordisk Investigational Site	Kazan		Russian Federation	420061
40	Novo Nordisk Investigational Site	Kemerovo		Russian Federation	650066
41	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
42	Novo Nordisk Investigational Site	Moscow		Russian Federation	119435
43	Novo Nordisk Investigational Site	Moscow		Russian Federation	127486
44	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	197110
45	Novo Nordisk Investigational Site	Saratov		Russian Federation	410002
46	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
47	Novo Nordisk Investigational Site	Voronezh		Russian Federation	394018
48	Novo Nordisk Investigational Site	Yaroslavl		Russian Federation	150040
49	Novo Nordisk Investigational Site	Al Ahsa		Saudi Arabia	36428
50	Novo Nordisk Investigational Site	Riyadh		Saudi Arabia	11525
51	Novo Nordisk Investigational Site	Riyadh		Saudi Arabia	12372
52	Novo Nordisk Investigational Site	Riyadh		Saudi Arabia	12713
53	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape	South Africa	6001
54	Novo Nordisk Investigational Site	Boksburg	Gauteng	South Africa	1466
55	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2013
56	Novo Nordisk Investigational Site	Pretoria	Gauteng	South Africa	0122
57	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4001
58	Novo Nordisk Investigational Site	Stanger, Durban	KwaZulu-Natal	South Africa	4450
59	Novo Nordisk Investigational Site	La Coruña		Spain	15006
60	Novo Nordisk Investigational Site	Madrid		Spain	28040
61	Novo Nordisk Investigational Site	Sevilla		Spain	41003
62	Novo Nordisk Investigational Site	Malmö		Sweden	205 02
63	Novo Nordisk Investigational Site	Stockholm		Sweden	112 81
64	Novo Nordisk Investigational Site	Stockholm		Sweden	141 86
65	Novo Nordisk Investigational Site	Örebro		Sweden	701 85

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05064735

Other Study ID Numbers:

NN9536-4578
U1111-1246-5824
2020-000204-11

First Posted:

Oct 1, 2021

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 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:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Obesity

Study Results

No Results Posted as of Jun 22, 2022