Research study looking at how well semaglutide works in people suffering from obesity and knee osteoarthritis

Effect of subcutaneous semaglutide 2.4 mg once-weekly compared to placebo in subjects with obesity and knee osteoarthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000204-11-DK

Enrollment

375

Registered

2020-12-01

Start date

2021-03-02

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Semaglutide B 3.0 mg/mL PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent - Body Mass Index (BMI) greater than or equal to 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 356 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm superiority of semaglutide subcutaneous (s.c.; under the skin) 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee osteoarthritis (OA) in change from baseline to week 68 in body weight and knee OA-related pain.;Secondary Objective: 1) To confirm superiority of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in achieving body weight response criteria after 68 weeks from baseline as well as change from baseline to week 68 in knee OA-related and general physical function. 2) To compare the efficacy of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in change from baseline to week 68 in waist circumference, knee OA-related stiffness, overall knee OA-related physical limitations, general health-related quality of life, and in use of analgesics;Primary end point(s): 1. Change in body weight 2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score;Timepoint(s) of evaluation of this end point: 1-2: From baseline (week 0) to end of treatment (week 68)	—

Measure

Time frame

Main Objective: To confirm superiority of semaglutide subcutaneous (s.c.; under the skin) 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee osteoarthritis (OA) in change from baseline to week 68 in body weight and knee OA-related pain.;Secondary Objective: 1) To confirm superiority of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in achieving body weight response criteria after 68 weeks from baseline as well as change from baseline to week 68 in knee OA-related and general physical function. 2) To compare the efficacy of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in change from baseline to week 68 in waist circumference, knee OA-related stiffness, overall knee OA-related physical limitations, general health-related quality of life, and in use of analgesics;Primary end point(s): 1. Change in body weight 2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score;Timepoint(s) of evaluation of this end point: 1-2: From baseline (week 0) to end of treatment (week 68)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Achieving body weight reduction =5% (yes/no) 2. Achieving body weight reduction =10% (yes/no) 3. Change in WOMAC physical function score 4. Change in SF-36 physical functioning score 5. Change in waist circumference 6. Change in WOMAC stiffness score 7. Change in WOMAC total score 8. Change in SF-36 bodily pain score 09. Change in SF-36 physical component summary 10. Change in SF-36 mental component summary 11. Use of allowed rescue analgesics during wash out 12. Amount of allowed rescue analgesics used during wash out 13. Change in pain medication 14. Change in pain intensity (NRS);Timepoint(s) of evaluation of this end point: 1.-14. From baseline (week 0) to end of treatment (week 68)	—

Measure

Time frame

Secondary end point(s): 1. Achieving body weight reduction =5% (yes/no) 2. Achieving body weight reduction =10% (yes/no) 3. Change in WOMAC physical function score 4. Change in SF-36 physical functioning score 5. Change in waist circumference 6. Change in WOMAC stiffness score 7. Change in WOMAC total score 8. Change in SF-36 bodily pain score 09. Change in SF-36 physical component summary 10. Change in SF-36 mental component summary 11. Use of allowed rescue analgesics during wash out 12. Amount of allowed rescue analgesics used during wash out 13. Change in pain medication 14. Change in pain intensity (NRS);Timepoint(s) of evaluation of this end point: 1.-14. From baseline (week 0) to end of treatment (week 68)

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Countries

Canada, Colombia, Denmark, European Union, France, Norway, Russian Federation, Saudi Arabia, South Africa, Sweden, United States

Contacts

Public ContactClinical Disclosure (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026