Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt

Conditions

• Muscle Loss
• Obesity

Eligibility Criteria

Sex

ALL

Age

60 Years - 100 Years

Healthy Volunteers

Accepted

Interventions

• Enobosarm — DRUG
  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.
• Semaglutide — DRUG
  Semaglutide for Chronic Weight Management

Study Details

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.

Key Dates

Start date

Apr 29, 2024

Status verified

Sep 2025

Primary completion

Apr 11, 2025

Completion

Aug 22, 2025

Study Design

Enrollment

168 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide and Enobosarm 3 mg QD by mouth (E3G) daily
  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.
• Experimental: Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily
  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.
• Placebo Comparator: GLP-1 receptor agonist and Placebo QD by mouth (PG) daily
  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.

Primary Outcome Measure

The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. [ Time Frame: Day 112 ]

Locations (14)

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