Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss

What Was Tested

This registered phase 2 trial tested Semaglutide for fat loss, obesity & body recomposition.

The primary objective of this study is to assess the effect of enobosarm on total body weight.

It had two arms (groups): one (experimental) and Subcutaneous injectable semaglutide and oral Placebo (placebo comparator).

Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo.

The registry classes the interventions as drug.

More on the Plan

This study is a multicenter, randomized, double-blind, and placebo-controlled study.

Who Took Part

239 actual participants took part.

It was open to people of any sex aged from 65 years up to 100 years.

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

Examples of who could join: Subjects accepted for this study must:. Provide informed consent from the subject or the subject's legally authorized representative. Be ≥65 years of age at the time of screening. For Female Subjects Menopausal status. One year or more of amenorrhea.

The full record lists 9 inclusion and 30 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; concurrently participating in any other interventional or treatment clinical trial.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2026-03-26 with completion listed for 2027-10.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone (time frame: Day 476).

It also tracked 1 secondary outcome, for example 1. 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 239 people with fat loss, obesity & body recomposition.

Its status is active not recruiting; 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.