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

NCT07446998 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-22

No results posted yet for this study

Summary

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

Conditions

  • Obesity & Overweight
  • Mobility Disability
  • HOMA-IR

Interventions

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

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446998 on ClinicalTrials.gov