Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients

Plain-language guide to NCT03034941: phase 4 randomized trial of Liraglutide, fat loss, obesity & body recomposition, 35 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03034941
Phase: phase 4
Status: completed
Start: 2014-04
Completion (planned or actual): 2016-12
Participants: 35 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Obesity; PCOS
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Liraglutide for fat loss, obesity & body recomposition and pcos.

It had three arms (groups): metformin group (active comparator), COMBI group (active comparator) and CONTROL group (no intervention).

Drug: metformin.

Drug: liraglutide + metformin.

Control group of obese PCOS patients without therapy.

The registry classes the interventions as drug.

More on the Plan

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity.

Who Took Part

35 actual participants took part.

It was open to women only aged from 18 years up to 38 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Polycystic ovary syndrome (rotterdam criteria). BMI of 30 kg/m² or higher. Infertility for IVF with normal male sperm.

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.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Nothing was hidden in this open-label Liraglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2014-04 with completion listed for 2016-12.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The main outcome was change in BMI (time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 35 people with fat loss, obesity & body recomposition.

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, Fat loss, obesity & body recomposition research, 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.

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.