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Selective Androgen Receptor Modulator

Enobosarm for Muscle Atrophy

Phase 2
Recruiting
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 112 and day 196
Awards & highlights

Summary

This trial aims to see if enobosarm can increase muscle mass in patients who are already taking GLP-1 receptor agonists.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, Enobosarm may cause symptoms like headache, nausea, fatigue, and hormonal imbalances. Semaglutide can lead to digestive issues such as nausea and diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 112 and day 196
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 112 and day 196 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.
Secondary outcome measures
The percent change from baseline in total fat mass

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enobosarm
2017
Completed Phase 2
~20
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Veru Inc.Lead Sponsor
10 Previous Clinical Trials
602 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
578 Total Patients Enrolled
~86 spots leftby Dec 2024