NCT06282458

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

A Phase 2 Dose-Finding and Proof-of-Concept Study to Evaluate the Effect on Body Composition and Safety of Enobosarm in Patients Treated With Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists for Chronic Weight Management

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Veru Inc. · Industry
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled, dose-assessing study. Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study. The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). 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. A safety follow up visit will occur approximately 30 days after last dose of study drug. The safety of enobosarm compared to the placebo control will be evaluated by an Independent Data Monitoring Committee (IDMC).

Conditions

• Muscle Loss
• Obesity

Interventions

Type	Name	Description
DRUG	Enobosarm	Enobosarm is an oral, new chemical entity class, SARM, that has demonstrated tissue-selective, dose-dependent improvement in body composition with increases in muscle mass and reduces fat mass, improves insulin resistance, has no masculinizing effects in women, has neutral prostate effects in men, and no increases in hematocrit. Increases in muscle mass have resulted in improvements in muscle strength and physical function.
DRUG	Semaglutide	Semaglutide for Chronic Weight Management

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-04-11
• Completion: 2025-08-22
• First posted: 2024-02-28
• Last updated: 2025-09-17

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study