← Trials/Trial dossier/NCT05064735

CompletedPhase 3Results posted

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

122

Recruiting sites

Enrollment

407

actual

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, % changeWOMAC pain

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05064735
Org study IDNN9536-4578
Secondary ID2020-000204-11
Secondary IDU1111-1246-5824WHO

Timeline

Milestones

Study first posted2021-10-01actual
Study start2021-10-01actual
Primary completion2023-07-24actual
Study completion2023-09-08actual
Results first posted2024-08-13actual
Last update posted2025-11-17actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

SexAll
Healthy volunteersAccepted

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

Endpoints (50)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
26
Weight & body composition
12
Patient-reported / QoL
11
Safety / tolerability / PK
1

Weight & body composition

12 endpoints
Primary/registry result

Percentage Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage change in body weight95% CI
Semaglutide 2.4 mg-14.2
Placebo-2.5
Estimated Treatment Difference-10.4895% CI-12.34-8.63p<0.0001ANCOVA

The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.

Primary/protocol endpoint

Percentage Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes87.0
No13.0
PlaceboYes29.2
No70.8
Secondary/registry result

Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes70.4
No29.6
PlaceboYes9.2
No90.8
Secondary/registry result

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 68)

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), Centimeter95% CI
Semaglutide 2.4 mg-13.3
Placebo-5.9
Secondary/registry result

Percentage of Participants Achieving Body Weight Reduction ≥ 15% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes47.8
No52.2
PlaceboYes2.5
No97.5
Secondary/registry result

Percentage of Participants Achieving Body Weight Reduction ≥ 20% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes23.3
No76.7
PlaceboYes0
No100
Secondary/protocol endpoint

Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 68)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Body Weight Reduction ≥ 15% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Body Weight Reduction ≥ 20% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

≥20% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

11 endpoints
Secondary/registry result

Change in Short Form 36 (SF-36) Physical Functioning Score

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 physical

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg12.7
Placebo6.4
Secondary/registry result

Change in SF-36 Bodily Pain Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg12.8
Placebo7.7
Secondary/registry result

Change in SF-36 Physical Component Summary

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 physical

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg13.2
Placebo6.9
Secondary/registry result

Change in SF-36 Mental Component Summary

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 mental

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg1.9
Placebo1.1
Secondary/registry result

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in SF-36 Physical Functioning Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

SF-36 physical

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes60.6
No39.4
PlaceboYes28.7
No71.3
Secondary/protocol endpoint

Change in Short Form 36 (SF-36) Physical Functioning Score

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in WOMAC Stiffness Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Bodily Pain Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Physical Component Summary

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Mental Component Summary

Time frame:Baseline (week 0), end of treatment (week 68)

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in SF-36 Physical Functioning Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

SF-36 physical

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Secondary/registry result

Amount of Allowed Rescue Analgesics Used During Wash Out

Time frame:At end of treatment (week 68)

descriptive

Posted result

GroupValue (mean), Milligram95% CI
Semaglutide 2.4 mg224.2
Placebo170.1

Other clinical outcomes

26 endpoints
Primary/registry result

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

Time frame:Baseline (week 0), end of treatment (week 68)

WOMAC pain

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg-43.7
Placebo-26.2
Estimated Treatment Difference-14.1495% CI-19.98-8.30p<0.0001ANCOVA

The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.

Primary/protocol endpoint

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

Time frame:Baseline (week 0), end of treatment (week 68)

WOMAC pain

change from baseline, improvement

Secondary/registry result

Change in WOMAC Physical Function Score

Time frame:Baseline (week 0), end of treatment (week 68)

WOMAC function

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg-43.4
Placebo-25.8
Secondary/registry result

Change in WOMAC Stiffness Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg-45.4
Placebo-27.6
Secondary/registry result

Change in WOMAC Total Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg-43.8
Placebo-26.0
Secondary/registry result

Percentage of Participants Using Allowed Rescue Analgesics During Wash Out (Yes/No)

Time frame:At end of treatment (week 68)

categorical status, descriptive

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes4.9
No95.1
PlaceboYes5.1
No94.9
Secondary/registry result

Percentage of Participants With Use of Pain Medication

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgOpioids8.5
NSAID55.7
Acetaminophen57.2
PlaceboOpioids9.6
NSAID59.6
Acetaminophen58.1
Secondary/registry result

Change in Pain Intensity (Numerical Rating Scale [NRS])

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide 2.4 mg-2.9
Placebo-1.4
Secondary/registry result

Percentage of Participants Achieving WOMAC Pain Reduction ≥ 30% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes78.8
No21.2
PlaceboYes56.4
No43.6
Secondary/registry result

Percentage of Participants Achieving WOMAC Pain Reduction ≥ 50% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes66.9
No33.1
PlaceboYes34.2
No65.8
Secondary/registry result

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Pain Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes61.2
No38.8
PlaceboYes33.3
No66.7
Secondary/registry result

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Physical Function Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC function

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes54.1
No45.9
PlaceboYes29.1
No70.9
Secondary/registry result

Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 30% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes64.8
No35.2
PlaceboYes39.0
No61.0
Secondary/registry result

Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 50% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes49.7
No50.3
PlaceboYes28.0
No72.0
Secondary/protocol endpoint

Change in WOMAC Physical Function Score

Time frame:Baseline (week 0), end of treatment (week 68)

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint

Change in WOMAC Total Score

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Using Allowed Rescue Analgesics During Wash Out (Yes/No)

Time frame:At end of treatment (week 68)

categorical status, descriptive

Secondary/protocol endpoint

Amount of Allowed Rescue Analgesics Used During Wash Out

Time frame:At end of treatment (week 68)

descriptive

Secondary/protocol endpoint

Percentage of Participants With Use of Pain Medication

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Secondary/protocol endpoint

Change in Pain Intensity (Numerical Rating Scale [NRS])

Time frame:Baseline (week 0), end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving WOMAC Pain Reduction ≥ 30% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving WOMAC Pain Reduction ≥ 50% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Pain Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC pain

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Physical Function Score (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

WOMAC function

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 30% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 50% (Yes/No)

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.