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Enobosarm

Phase 2

Muscle Loss | Small molecule | Metabolic |Veru Inc.|Last Updated: Sep 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06282458Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight MgmtPHASE2 COMPLETED 168Apr 29, 2024Aug 22, 2025Sep 17, 202514 United States
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Study Endpoints
Primary Endpoints
The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.
Day 112

To determine the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists (percent change in total lean mass) at 112 days.

Secondary Endpoints
The percent change from baseline in total fat mass
Day 112 and Day 196
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Semaglutide and Enobosarm 3 mg QD by mouth (E3G) dailyEXPERIMENTALApproximately 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.
Semaglutide and Enobosarm 6 mg QD by mouth (E6G) dailyEXPERIMENTALApproximately 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.
GLP-1 receptor agonist and Placebo QD by mouth (PG) dailyPLACEBO_COMPARATORApproximately 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.
Interventions
NameTypeDescription
EnobosarmDRUGEnobosarm 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.
SemaglutideDRUGSemaglutide for Chronic Weight Management
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Eligibility Criteria
Age Range60 Years — 100 Years
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: Subjects accepted for this study must: 1. Provide informed consent from the subject or the subject's legally authorized representative 2. Be able to communicate effectively with the study personnel 3. Aged ≥60 years 4. For Female Subjects * Menopausal status * Be post...

Countries:United States
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Competitive Landscape -Muscle Disorders 4 trials
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