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Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
Plain-language guide to NCT05064735: phase 3 randomized trial of Semaglutide, 407 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05064735
- Phase
- phase 3
- Status
- completed
- Start
- 2021-10-01
- Completion (planned or actual)
- 2023-07-24
- Participants
- 407 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Semaglutide.
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.
It had two arms (groups): one (experimental) and one (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
407 actual participants took part.
It was open to people of any sex.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 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. Pain due to knee OA.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: 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.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2021-10-01 with completion listed for 2023-07-24.
It ran at 122 sites in United States (61), Canada (16), Russia (10), France (9), South Africa (6) and Colombia (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Percentage Change in Body Weight (time frame: Baseline (week 0), end of treatment (week 68)). Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (time frame: Baseline (week 0), end of treatment (week 68)).
It also tracked 23 secondary outcomes, for example Change in WOMAC Physical Function Score, Change in Short Form 36 (SF-36) Physical Functioning Score, Change in Waist Circumference, Change in WOMAC Stiffness Score, Change in WOMAC Total Score and Change in SF-36 Bodily Pain Score.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 407 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.