Enobosarm for Muscle Atrophy

(QUALITY Trial)

Recruiting at 15 trial locations

Overseen By Steven Geller

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Veru Inc.

Must be taking: GLP-1 receptor agonists

Must not be taking: Testosterone, Antiandrogens

Disqualifiers: Diabetes, Liver disease, Psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

150 Participants Needed

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.

Research Team

Barnette

Principal Investigator

Veru Inc.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide and enobosarm or placebo for approximately 16 weeks with dose escalation of semaglutide

16 weeks

Weekly visits for semaglutide dose escalation

Monotherapy Treatment

Participants continue enobosarm or placebo monotherapy from Day 112 to Day 196 after discontinuation of semaglutide

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 safety follow-up visit

Treatment Details

Interventions

• Enobosarm

Trial Overview 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.

Participant Groups

Group I: Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily Experimental Treatment 2 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) daily Experimental Treatment 2 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) daily Placebo Group 1 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.

Who Is Running the Clinical Trial?

Veru Inc.

Lead Sponsor

Trials

11

Recruited

750+