NCT07446998

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

PLATEAU: Phase 2b Proof-of-Concept Study to Evaluate the Effect on Total Body Weight, Physical Function and Safety of Enobosarm in Patients Treated With Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist, for Weight Reduction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Veru Inc. · Industry
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a multicenter, randomized, double-blind, and placebo-controlled study. Subjects will be randomized into two treatment arms (subcutaneous injectable semaglutide plus oral enobosarm 3mg dose group or subcutaneous injectable semaglutide plus placebo group) in a 1:1 fashion. All patients randomized into this study will initiate semaglutide subcutaneous injection therapy for weight reduction on Day 1 of this study. The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 68 weeks (476 days). A safety follow up visit will occur approximately 30 days after last dose of study drug.

Conditions

• Obesity & Overweight
• Mobility Disability
• HOMA-IR

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 (Wegovy) weekly injection	Semaglutide for Chronic Weight Management

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2026-03-03
• Last updated: 2026-03-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study