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Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
Plain-language guide to NCT03619330: phase 4 randomized trial of Liraglutide, fat loss, obesity & body recomposition, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03619330
- Phase
- phase 4
- Status
- completed
- Start
- 2014-12
- Completion (planned or actual)
- 2015-08
- Participants
- 30 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypogonadism; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Liraglutide for fat loss, obesity & body recomposition.
The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.
It had two arms (groups): liraglutide (active comparator) and testosterone (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 30 actual participants took part.
It was open to men only aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The fat loss, obesity & body recomposition participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
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 2014-12 with completion listed for 2015-08.
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 testosterone level (time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial). the main outcome was change in gonadotropin levels (time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial).
It also tracked 2 secondary outcomes, for example The secondary outcome was change in body weight and The secondary outcome was change in waist circumference.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 30 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.
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.