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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: semaglutide 2.4 mg (placebo); Drug: semaglutide 2.4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05064735

U1111-1246-5824 (Other Identifier)

2020-000204-11 (EudraCT Number)

NN9536-4578

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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407 participants in 2 patient groups, including a placebo group

semaglutide 2.4 mg

Experimental group

Description:

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

Treatment:

Drug: semaglutide 2.4 mg

semaglutide 2.4 mg (placebo)

Placebo Comparator group

Description:

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

Treatment:

Drug: semaglutide 2.4 mg (placebo)