Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
Completed · Phase 3 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT05064735
- Run by
- Novo Nordisk A/S
- People needed
- 407
- Starts
- 2021-10-01
- Expected to finish
- 2023-09-08
- Last updated by the study team
- 2025-11-17
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ortho Arizona — Phoenix, Arizona, United States
- Anaheim Clinical Trials, LLC — Anaheim, California, United States
- Stuart L. Silverman MD - A Medical Corporation — Beverly Hills, California, United States
- Valley Research — Fresno, California, United States
- Providence Medical Foundation — Fullerton, California, United States
- Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
- Encompass Clinical Research_Spring Valley — Spring Valley, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Clinical Research of Hollywood_Hollywood — Hollywood, Florida, United States
- Westside Center For Clinical Research — Jacksonville, Florida, United States
- Jacksonville Ctr For Clin Res — Jacksonville, Florida, United States
- Well Pharma Medical Research Corp — Miami, Florida, United States
- Renstar Medical Research — Ocala, Florida, United States
- Clinical Trial Res Assoc,Inc — Plantation, Florida, United States
- East West Medical Research Institute_Honolulu — Honolulu, Hawaii, United States
- Clinical Invest Special_Gurnee — Gurnee, Illinois, United States
- Evanston Premier Hlthcr Res — Skokie, Illinois, United States
- Clinical Invest Special_Gurnee — Wauconda, Illinois, United States
- MediSphere Medical RC — Evansville, Indiana, United States
- Velocity Clin. Res Valparaiso — Valparaiso, Indiana, United States
- KU MedWest — Shawnee Mission, Kansas, United States
- L-MARC Research Center — Louisville, Kentucky, United States
- Maryland Veterans Administration Health Care System — Baltimore, Maryland, United States
- Centennial Medical Group — Elkridge, Maryland, United States
- Baptist Health System — Montgomery, Alabama, United States
Full record on ClinicalTrials.gov
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