Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Veru Inc.
Study ID
NCT07446998
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • HOMA-IR
  • Mobility Disability
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
65 Years - 100 Years
Healthy Volunteers
Not 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 (Wegovy) weekly injection — DRUG
    Semaglutide for Chronic Weight Management

Study Details

The primary objective of this study is to assess the effect of enobosarm on total body weight

Key Dates

First listed
Mar 3, 2026
Start date
Mar 26, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
239 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subcutaneous injectable semaglutide and oral enobosarm 3mg
    Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD
  • Placebo Comparator: Subcutaneous injectable semaglutide and oral Placebo
    Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo

Primary Outcome Measure

To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone. [ Time Frame: Day 476 ]

Locations (13)

FacilityCityStateZIPSite coordinators
DM Clinical Research - PhoenixPhoenixArizona85012-
DM Clinical Research - MIADoralFlorida33166-
Universal Axon Clinical Research (Rovia - UACR)DoralFlorida33166-
IMIC Research a Rovia Clinical Research CompanyMiamiFlorida33176-
Paramo HealthMiamiFlorida33175-
Paramo HealthMiamiFlorida33176-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Centennial Medical Group (CMG)ColumbiaMaryland21045-
SKY Integrative Medical CenterRidgelandMississippi39157-
ALSA ResearchNew YorkNew York10016-
Coastal Research Institute, LLCFayettevilleNorth Carolina28304-
DM Clinical - DallasIrvingTexas75061-
DM Clinical - SeattleSeattleWashington98122-

Find similar trials in Phoenix, AZ

By research site
DM Clinical Research - Phoenix· Phoenix, AZDM Clinical Research - MIA· Doral, FLUniversal Axon Clinical Research (Rovia - UACR)· Doral, FLIMIC Research a Rovia Clinical Research Company· Miami, FLParamo Health· Miami, FLPennington Biomedical Research Center· Baton Rouge, LA

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