Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt

What Was Tested

The trial (phase 2) is built around Semaglutide for fat loss, obesity & body recomposition.

The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists.

It had three arms (groups): one (experimental), one (experimental) and GLP-1 receptor agonist and Placebo QD by mouth (PG) daily (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management.

Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists.

The safety of enobosarm compared to the placebo control will be evaluated by an Independent Data Monitoring Committee (IDMC).

Who Took Part

168 actual participants took part.

It was open to people of any sex aged from 60 years up to 100 years.

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

Examples of who could join: Provide informed consent from the subject or the subject's legally authorized representative. Aged ≥60 years. For Female Subjects. Be postmenopausal as defined by either:. One year or more of amenorrhea.

The full record lists 21 inclusion and 27 exclusion criteria; among the exclusions: known hypersensitivity or allergy to enobosarm or a glp-1 receptor agonist; treatment with any investigational product within \< 5 half-lives for each individual investigational product or within 30 days prior to randomization; major surgery within 30 days prior to randomization.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-04-29 with completion listed for 2025-04-11.

It ran at 14 sites in United States (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days (time frame: Day 112).

It also tracked 1 secondary outcome, for example The percent change from baseline in total fat mass.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 168 people with fat loss, obesity & body recomposition.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.