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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
semaglutide 2.4 mg
semaglutide 2.4 mg (placebo)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

semaglutide 2.4 mg

semaglutide 2.4 mg (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in body weight
Percentage
Change in WOMAC pain score
Score points

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2021
Last Updated
October 18, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05064735
Brief Title
Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
Official Title
Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
September 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
semaglutide 2.4 mg
Arm Type
Experimental
Arm Description
Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity
Arm Title
semaglutide 2.4 mg (placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
Intervention Type
Drug
Intervention Name(s)
semaglutide 2.4 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
semaglutide 2.4 mg (placebo)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in body weight
Description
Percentage
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in WOMAC pain score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Secondary Outcome Measure Information:
Title
Achieving body weight reduction greater than or equal to 5% (yes/no)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Achieving body weight reduction greater than or equal to 10% (yes/no)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in WOMAC physical function score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in SF-36 physical functioning score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in waist circumference
Description
cm
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in WOMAC stiffness score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in WOMAC total score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in SF-36 bodily pain score
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in SF-36 physical component summary
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in SF-36 mental component summary
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Use of allowed rescue analgesics during wash out
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Amount of allowed rescue analgesics used during wash out
Description
Dose
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in pain medication
Description
Dose
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in pain intensity (NRS)
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3Z 2N6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Novo Nordisk Investigational Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Novo Nordisk Investigational Site
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Novo Nordisk Investigational Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
PARIS cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Toulouse
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nordbyhagen
ZIP/Postal Code
1474
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Tønsberg
ZIP/Postal Code
3117
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410002
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Yaroslavl
ZIP/Postal Code
150047
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Al Ahsa
ZIP/Postal Code
36428
Country
Saudi Arabia
Facility Name
Novo Nordisk Investigational Site
City
Riyadh
ZIP/Postal Code
12372
Country
Saudi Arabia
Facility Name
Novo Nordisk Investigational Site
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Facility Name
Novo Nordisk Investigational Site
City
Riyadh
ZIP/Postal Code
21451
Country
Saudi Arabia
Facility Name
Novo Nordisk Investigational Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1466
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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