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Phase 3 N=407 Randomized Triple-blind Treatment

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

Obesity

Enrolled (actual)
407
Serious AEs
9.4%
Results posted
Aug 2024
Primary outcome: Primary: Percentage Change in Body Weight — -14.2; -2.5 Percentage change in body weight — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
semaglutide 2.4 mg (Drug); semaglutide 2.4 mg (placebo) (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Novo Nordisk A/S
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage Change in Body Weight
-14.2; -2.5 <0.0001 sig
PRIMARY
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
-43.7; -26.2 <0.0001 sig
SECONDARY
Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)
87.0; 29.2; 13.0; 70.8
SECONDARY
Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)
70.4; 9.2; 29.6; 90.8
SECONDARY
Change in WOMAC Physical Function Score
-43.4; -25.8
SECONDARY
Change in Short Form 36 (SF-36) Physical Functioning Score
12.7; 6.4
SECONDARY
Change in Waist Circumference
-13.3; -5.9
SECONDARY
Change in WOMAC Stiffness Score
-45.4; -27.6
SECONDARY
Change in WOMAC Total Score
-43.8; -26.0
SECONDARY
Change in SF-36 Bodily Pain Score
12.8; 7.7
SECONDARY
Change in SF-36 Physical Component Summary
13.2; 6.9
SECONDARY
Change in SF-36 Mental Component Summary
1.9; 1.1
SECONDARY
Percentage of Participants Using Allowed Rescue Analgesics During Wash Out (Yes/No)
4.9; 5.1; 95.1; 94.9
SECONDARY
Amount of Allowed Rescue Analgesics Used During Wash Out
224.2; 170.1
SECONDARY
Percentage of Participants With Use of Pain Medication
8.5; 9.6; 55.7; 59.6; 57.2; 58.1
SECONDARY
Change in Pain Intensity (Numerical Rating Scale [NRS])
-2.9; -1.4
SECONDARY
Percentage of Participants Achieving Body Weight Reduction ≥ 15% (Yes/No)
47.8; 2.5; 52.2; 97.5
SECONDARY
Percentage of Participants Achieving Body Weight Reduction ≥ 20% (Yes/No)
23.3; 0; 76.7; 100
SECONDARY
Percentage of Participants Achieving WOMAC Pain Reduction ≥ 30% (Yes/No)
78.8; 56.4; 21.2; 43.6
SECONDARY
Percentage of Participants Achieving WOMAC Pain Reduction ≥ 50% (Yes/No)
66.9; 34.2; 33.1; 65.8
SECONDARY
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Pain Score (Yes/No)
61.2; 33.3; 38.8; 66.7
SECONDARY
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Physical Function Score (Yes/No)
54.1; 29.1; 45.9; 70.9
SECONDARY
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in SF-36 Physical Functioning Score (Yes/No)
60.6; 28.7; 39.4; 71.3
SECONDARY
Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 30% (Yes/No)
64.8; 39.0; 35.2; 61.0
SECONDARY
Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 50% (Yes/No)
49.7; 28.0; 50.3; 72.0

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05064735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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