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Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
Plain-language guide to NCT02909933: phase 4 randomized trial of Liraglutide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02909933
- Phase
- phase 4
- Status
- completed
- Start
- 2015-07
- Completion (planned or actual)
- 2015-10
- Participants
- 30 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Polycystic Ovary Syndrome; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Liraglutide.
Metformin could enhance weight lowering potential of liraglutide.
It had two arms (groups): liraglutide (experimental) and metformin and liraglutide (experimental).
The registry classes the interventions as drug.
Who Took Part
30 actual participants took part.
It was open to women only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 18 years old to menopause. Polycystic ovary syndrome (NICHD criteria). BMI of 30 kg/m² or higher.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; history of carcinoma; cushing's syndrome or congenital (non-classic) adrenal hyperplasia.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2015-07 with completion listed for 2015-10.
It ran at 1 site in Slovenia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): The main outcome was change in body weight (time frame: Patient's body weight was measured at the base point and after 12 weeks of clinical trial).
It also tracked 1 secondary outcome, for example The secondary outcome was change in body mass index (BMI).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 30 people.
Its size is small, so on its own it can only give an early look.
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.