← Human Trials & Peer-Reviewed Studies
Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome
Plain-language guide to NCT02483299: phase 4 randomized trial of Liraglutide, pcos, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02483299
- Phase
- phase 4
- Status
- completed
- Start
- 2014-01
- Completion (planned or actual)
- 2015-04
- Participants
- 40 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- PCOS; 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 for pcos.
The researchers anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.
It had two arms (groups): metformin (active comparator) and combined (active comparator).
The registry classes the interventions as drug.
Who Took Part
40 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
The set-up was randomized, parallel-group and open-label.
Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Liraglutide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Liraglutide study: the pcos participants and staff both knew the treatment.
It started in 2014-01 with completion listed for 2015-04.
It ran at 1 site in Slovenia.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in body weight (time frame: up to 12 weeks of clinical trial). The number of good responders to combined treatment regarding body weight (time frame: up to 12 weeks of clinical trial).
It also tracked 2 secondary outcomes, for example Change in body mass index (BMI) and Change in waist circumference.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 40 people with pcos.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, PCOS research.
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.