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Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
Plain-language guide to NCT02718950: phase 3 interventional trial of Liraglutide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02718950
- Phase
- phase 3
- Status
- status unknown
- Start
- 2016-06
- Completion (planned or actual)
- 2017-03
- Participants
- 20 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity; Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Liraglutide.
The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
20 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body mass index over 30 kg/m2.
The full record lists 1 inclusion and 25 exclusion criteria; among the exclusions: hypersensitivity to liraglutide or any of its vehicle components;; history of diabetes or pre-diabetes - either by fasting glycemia, ogtt or hba1c;; liver diseases, except non-alcoholic steatohepatitis (nash);.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Liraglutide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-06 with completion listed for 2017-03.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans (time frame: 2 weeks).
It also tracked 5 secondary outcomes, for example Evaluate the effect of liraglutide administration on hypothalamic activation in humans, Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans, Evaluate the effect of liraglutide administration on body weight in humans, Evaluate the effect of liraglutide administration on metabolic basal rate in humans and Evaluate the effect of liraglutide administration on body composition in humans.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Liraglutide in 20 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; 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.