Liver and Fat Regulation in Overweight Adolescent Girls

Plain-language guide to NCT02157974: phase 2, phase 3 non-randomized trial of Exenatide, 92 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02157974
Phase: phase 2, phase 3
Status: completed
Start: 2014-08
Completion (planned or actual): 2022-12
Participants: 92 (actual)
Design: non-randomized, open label (everyone knows who gets what), other
Conditions studied: Hepatic Steatosis; Polycystic Ovarian Syndrome; Obesity
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Exenatide.

It is unclear if this is related to high testosterone or insulin resistance.

It had five arms (groups): PCOS, medication naive + Byetta (experimental), Control (no intervention), PCOS medication naive (no intervention), PCOS on COCPs (no intervention) and PCOS on metformin (no intervention).

Up to 25 girls without PCOS.

Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.

The registry classes the interventions as drug.

More on the Plan

Data will be collected fasting and after a glucose challenge.

The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).

Who Took Part

Enrollment: 92 actual participants took part.

It was open to women only aged from 12 years up to 21 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 2 years post-menarche.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: liver disease; medications known to effect insulin sensitivity; cause of oligomenorrhea or hirsutism other than pcos,.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-08 with completion listed for 2022-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Hepatic Glucose Release (time frame: Measured up to 4 months from enrollment).

It also tracked 4 secondary outcomes, for example Hepatic Phosphate Concentrations, Rates of Lipolysis and Hepatic Fat Fraction.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Exenatide in 92 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Exenatide in the library

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.