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Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance
Plain-language guide to NCT02928614: phase 4 randomized trial of Liraglutide, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02928614
- Phase
- phase 4
- Status
- completed
- Start
- 2016-11
- Completion (planned or actual)
- 2019-02
- Participants
- 150 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Osteoarthritis; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide.
This is a substudy to a randomized trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).
It had two arms (groups): one (experimental) and one (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 150 planned participants were the target.
It was open to people of any sex aged from 18 years up to 74 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Same as parent trial (NCT02905864).
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: same as parent trial (nct02905864).
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.
The Liraglutide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2016-11 with completion listed for 2019-02.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in collagen II degradation fragment α-C2M (time frame: Week 0 to 52).
It also tracked 5 secondary outcomes, for example Change in collagen II degradation fragment β-C2M, Change in non-coding RNA type snoRNAs U38 and U48, Change in miRNA-454, Change in miRNA let-7e and Change in Nesfatin-1.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 150 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.