Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
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| ClinicalTrials.gov Identifier: NCT05064735 |
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Recruitment Status :
Completed
First Posted : October 1, 2021
Last Update Posted : January 16, 2024
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 407 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 : | October 1, 2021 |
| Actual Primary Completion Date : | July 24, 2023 |
| Actual Study Completion Date : | September 8, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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
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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 |
- Change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Percentage
- Change in WOMAC pain score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Achieving body weight reduction greater than or equal to 5% (yes/no) [ Time Frame: 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) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Count of subjects
- Change in WOMAC physical function score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in SF-36 physical functioning score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]cm
- Change in WOMAC stiffness score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in WOMAC total score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in SF-36 bodily pain score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in SF-36 physical component summary [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Change in SF-36 mental component summary [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
- Use of allowed rescue analgesics during wash out [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Count of subjects
- Amount of allowed rescue analgesics used during wash out [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Dose
- Change in pain medication [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Dose
- Change in pain intensity (NRS) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]Score points
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064735
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| Study Director: | Clinical Transparency (Dept. 2834) | Novo Nordisk A/S |
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT05064735 |
| Other Study ID Numbers: |
NN9536-4578 U1111-1246-5824 ( Other Identifier: WHO ) 2020-000204-11 ( EudraCT Number ) |
| First Posted: | October 1, 2021 Key Record Dates |
| Last Update Posted: | January 16, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
| URL: | http://novonordisk-trials.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Osteoarthritis Osteoarthritis, Knee Obesity Overweight Overnutrition Nutrition Disorders Body Weight Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Semaglutide Glucagon-Like Peptide-1 Receptor Agonists Hypoglycemic Agents Physiological Effects of Drugs |