Enobosarm for Muscle Atrophy
(QUALITY Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Veru Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for men and women aged 60 or older who are experiencing muscle loss while managing chronic weight with a GLP-1 receptor agonist. Women must be postmenopausal, either naturally or through surgery. Participants must use effective contraception if there's any chance of pregnancy in their partners.

Inclusion Criteria

Documented evidence of obesity (BMI ≥30 or ≥27 with the presence of at least one weight-related comorbid condition)

Maximum weight at screening of 300lbs as per DEXA requirements

Complete a valid OSA assessment

+10 more

Exclusion Criteria

I do not have any health issues that prevent me from using semaglutide.

Baseline total bilirubin levels > upper limit of normal

Concurrently participating in any other interventional or treatment clinical trial

+22 more

Participant Groups

The study is testing the effects of Enobosarm on body composition, specifically lean muscle mass, in patients already taking Semaglutide for weight management. The effectiveness will be measured using DEXA scans to track changes in lean mass.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Semaglutide and Enobosarm 6 mg QD by mouth (E6G) dailyExperimental Treatment2 Interventions

Approximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 6 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 6 mg enobosarm QD by mouth and will discontinue the semaglutide.

Group II: Semaglutide and Enobosarm 3 mg QD by mouth (E3G) dailyExperimental Treatment2 Interventions

Approximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 3 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 3 mg enobosarm QD by mouth and will discontinue the semaglutide.

Group III: GLP-1 receptor agonist and Placebo QD by mouth (PG) dailyPlacebo Group1 Intervention

Approximately 50 subjects will be dosed with semaglutide injected once-weekly and placebo QD by mouth (PG) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive placebo QD by mouth (PG) and will discontinue the semaglutide.