Trial · NCT05064735
Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
NCT05064735, Phase 3, Completed, Novo Nordisk A/S; results first posted 2024-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis. Trials, record NCT05064735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05064735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
- NCT number
- NCT05064735
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 407 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Obesity
- Interventions
- semaglutide 2.4 mg, semaglutide 2.4 mg (placebo)
- First posted
- 2021-10-01
- Last updated
- 2025-11-17
- Other registries' IDs
- eudract:2020-000204-11
- Results first posted
- 2024-08-13
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Body Weight | Baseline (week 0), end of treatment (week 68) | Percentage change in body weight from baseline (week 0) to end of treatment (week 68) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Primary | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score | Baseline (week 0), end of treatment (week 68) | WOMAC is a disease-specific patient-reported outcome measure designed to assess changes in symptoms and lower extremity functioning associated with treatment in patients with osteoarthritis of the hip and/or knee. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with osteoarthritis (OA). It consists of 3 subscales: pain, stiffness and physical function. The WOMAC raw pain score is derived as the sum of the 5 item scores in the pain domain. It will be normalised and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the pain domain (i.e. 50) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | From baseline (week 0) to end of treatment (week 68) | Percentage of participants who achieved ≥ 5% body weight reduction (yes/no) from baseline (week 0) to end of treatment (week 68) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved ≥5% weight reduction whereas 'No' infers percentage of participants who have not achieved ≥5% weight reduction. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No) | From baseline (week 0) to end of treatment (week 68) | Percentage of participants who achieved ≥10% body weight reduction (yes/no) from baseline (week 0) to end of treatment (week 68) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved ≥10% weight reduction whereas 'No' infers percentage of participants who have not achieved ≥10% weight reduction. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in WOMAC Physical Function Score | Baseline (week 0), end of treatment (week 68) | Change in WOMAC physical function score is presented. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with osteoarthritis (OA). It consists of 3 subscales: pain, stiffness and physical function. WOMAC physical function is 17-item questionnaire used to assess degree of difficulty experienced due to OA in knee. It is calculated as the sum of the 17 item scores in the physical function domain. It is normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the physical function domain (i.e. 170) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in Short Form 36 (SF-36) Physical Functioning Score | Baseline (week 0), end of treatment (week 68) | SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status. A positive change score indicates an improvement since baseline. The outcome measure was evaluated based on data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in Waist Circumference | Baseline (week 0), end of treatment (week 68) | Change in waist circumference from baseline (week 0) to end of the treatment (visit 68) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in WOMAC Stiffness Score | Baseline (week 0), end of treatment (week 68) | WOMAC is a disease-specific patient-reported outcome measure designed to assess changes in symptoms and lower extremity functioning associated with treatment in patients with osteoarthritis of the hip and/or knee. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with OA. It consists of 3 subscales: pain, stiffness and physical function. The WOMAC raw stiffness score is derived as the sum of the 2 item scores in the stiffness domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the stiffness domain (i.e. 20) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in WOMAC Total Score | Baseline (week 0), end of treatment (week 68) | WOMAC is a disease-specific patient-reported outcome measure designed to assess changes in symptoms and lower extremity functioning associated with treatment in patients with osteoarthritis of the hip and/or knee. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with OA. The WOMAC raw total score is derived as the sum of the 24 item scores respectively on pain, stiffness and physical function domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the total domain (i.e. 240) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in SF-36 Bodily Pain Score | Baseline (week 0), end of treatment (week 68) | Change in SF-36 Bodily Pain Score from baseline (week 0) to end of treatment (week 68) is presented. SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary and mental component summary. Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status. A positive change score indicates an improvement since baseline. The outcome measure was evaluated based on data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Body Weight | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage change in body weight | MEAN |
| PRIMARY | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | From baseline (week 0) to end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No) | From baseline (week 0) to end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Change in WOMAC Physical Function Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change in Short Form 36 (SF-36) Physical Functioning Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change in Waist Circumference | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Centimeter | MEAN |
| SECONDARY | Change in WOMAC Stiffness Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change in WOMAC Total Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change in SF-36 Bodily Pain Score | Baseline (week 0), end of treatment (week 68) | FAS included all randomized participants according to the intention-to-treat principle. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Score on a scale | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Body Weight | Semaglutide 2.4 mg | -14.2 | Standard Deviation 8.6 | Percentage change in body weight | |
| Percentage Change in Body Weight | Placebo | -2.5 | Standard Deviation 5.6 | Percentage change in body weight | |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score | Semaglutide 2.4 mg | -43.7 | Standard Deviation 25.3 | Score on a scale | |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score | Placebo | -26.2 | Standard Deviation 25.0 | Score on a scale | |
| Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | Semaglutide 2.4 mg | Yes | 87.0 | Percentage of participants | |
| Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | Placebo | Yes | 29.2 | Percentage of participants | |
| Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | Semaglutide 2.4 mg | No | 13.0 | Percentage of participants | |
| Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No) | Placebo | No | 70.8 | Percentage of participants | |
| Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No) | Semaglutide 2.4 mg | Yes | 70.4 | Percentage of participants | |
| Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No) | Placebo | Yes | 9.2 | Percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide 2.4 mg | 271 | |
| Overall Study | STARTED | Placebo | 136 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 271 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 136 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 269 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 135 | |
| Overall Study | COMPLETED | Semaglutide 2.4 mg | 246 | |
| Overall Study | COMPLETED | Placebo | 122 | |
| Overall Study | NOT COMPLETED | Semaglutide 2.4 mg | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Semaglutide 2.4 mg | 8 | 269 | 11 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 13 | 135 | 13 |
| other | COVID-19 | Infections and infestations | Semaglutide 2.4 mg | 50 | 269 | 54 |
| other | COVID-19 | Infections and infestations | Placebo | 30 | 135 | 31 |
| other | Constipation | Gastrointestinal disorders | Semaglutide 2.4 mg | 32 | 269 | 35 |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 135 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Semaglutide 2.4 mg | 21 | 269 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 135 | 8 |
| other | Headache | Nervous system disorders | Semaglutide 2.4 mg | 16 | 269 | 18 |
| other | Headache | Nervous system disorders | Placebo | 5 | 135 | 5 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide 2.4 mg | 0 | 269 |
| Total, all-cause mortality | Placebo | 0 | 135 |
| Total, other adverse events | Semaglutide 2.4 mg | 128 | 269 |
| Total, other adverse events | Placebo | 51 | 135 |
| Total, serious adverse events | Semaglutide 2.4 mg | 27 | 269 |
| Total, serious adverse events | Placebo | 11 | 135 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39476339 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide 2.4 mg vs Placebo: deaths from any cause | Trial comparisons |
| Semaglutide 2.4 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05064735
GET https://conductscience.org/api/trials/v1/NCT05064735/registered?page=2