Primary outcome
What NCT05064735 measured first
| Semaglutide 2.4 mgn=253 | Placebon=120 |
|---|---|
| -14.2(8.6) | -2.5(5.6) |
| Semaglutide 2.4 mgn=245 | Placebon=117 |
|---|---|
| -43.7(25.3) | -26.2(25.0) |
Phase 3 · Semaglutide
NCT05064735 trial results
Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
Percentage Change in Body Weight (Percentage change in body weight), Baseline (week 0), end of treatment (week 68). Semaglutide 2.4 mg: -14.2; Placebo: -2.5.
- Participants
- 407
- Status
- completed
- Completed
- 2023-09-08
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT05064735), updated at source Nov 17, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT05064735
Percent of participants affected, From baseline (week 0) to end of trial (week 75). The most common events the registry lists.
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Any serious event | 10% | 8.1% |
| COVID-19 | 18.6% | 22.2% |
| Nausea | 21.9% | 8.9% |
| Constipation | 11.9% | 5.2% |
| Arthralgia | 3% | 9.6% |
| Diarrhoea | 7.8% | 5.2% |
| Vomiting | 7.8% | 0.7% |
| Headache | 5.9% | 3.7% |
| Upper respiratory tract infection | 4.5% | 5.2% |
Secondary outcomes
What else it measured
| Measure | Semaglutide 2.4 mgn=253 | Placebon=120 |
|---|---|---|
| Yes | 87.0 | 29.2 |
| No | 13.0 | 70.8 |
| Measure | Semaglutide 2.4 mgn=253 | Placebon=120 |
|---|---|---|
| Yes | 70.4 | 9.2 |
| No | 29.6 | 90.8 |
| Semaglutide 2.4 mgn=246 | Placebon=117 |
|---|---|
| -43.4(25.5) | -25.8(25.1) |
| Semaglutide 2.4 mgn=241 | Placebon=115 |
|---|---|
| 12.7(9.9) | 6.4(9.8) |
| Semaglutide 2.4 mgn=253 | Placebon=120 |
|---|---|
| -13.3(9.3) | -5.9(10.4) |
| Semaglutide 2.4 mgn=246 | Placebon=117 |
|---|---|
| -45.4(27.7) | -27.6(29.3) |
| Semaglutide 2.4 mgn=245 | Placebon=117 |
|---|---|
| -43.8(24.9) | -26.0(24.9) |
| Semaglutide 2.4 mgn=241 | Placebon=115 |
|---|---|
| 12.8(9.4) | 7.7(10.0) |
| Semaglutide 2.4 mgn=241 | Placebon=115 |
|---|---|
| 13.2(9.1) | 6.9(9.3) |
| Semaglutide 2.4 mgn=241 | Placebon=115 |
|---|---|
| 1.9(11.3) | 1.1(11.6) |
| Measure | Semaglutide 2.4 mgn=246 | Placebon=117 |
|---|---|---|
| Yes | 4.9 | 5.1 |
| No | 95.1 | 94.9 |
| Semaglutide 2.4 mgn=246 | Placebon=117 |
|---|---|
| 224.2(1756.4) | 170.1(1100.3) |
The trial
How NCT05064735 was run
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.
- 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
- 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
Who could join the trial
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
Published papers
Papers from NCT05064735
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.