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
- Recruiting
Conditions
- HOMA-IR
- Mobility Disability
- Obesity & Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Enobosarm — DRUGEnobosarm 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 — DRUGSemaglutide 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
- Start date
- Mar 26, 2026
- Status verified
- Apr 2026
- Primary completion
- Oct 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Subcutaneous injectable semaglutide and oral enobosarm 3mgApproximately 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 PlaceboApproximately 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 ]
Central Contacts
- Gary Barnette8006069382
- Domingo Rodriguez8006069382
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| DM Clinical Research - Phoenix | Phoenix | Arizona | 85012 | Arvind Mahadevan, MD (PRINCIPAL_INVESTIGATOR) |
| DM Clinical Research - MIA | Doral | Florida | 33166 | Noreen Shaaban, MD (PRINCIPAL_INVESTIGATOR) |
| Universal Axon Clinical Research (Rovia - UACR) | Doral | Florida | 33166 | Luis Martinez (PRINCIPAL_INVESTIGATOR) |
| IMIC Research a Rovia Clinical Research Company | Miami | Florida | 33176 | Ramon Leon, MD (PRINCIPAL_INVESTIGATOR) |
| Paramo Health | Miami | Florida | 33175 | Didiet Solano Perez (PRINCIPAL_INVESTIGATOR) |
| Paramo Health | Miami | Florida | 33176 | Ladynez Espinal, MD (PRINCIPAL_INVESTIGATOR) |
| UD Research | Atlanta | Georgia | 30342 | Marc Sonenshine, MD (PRINCIPAL_INVESTIGATOR) |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | Stephen Heymsfield, MD (PRINCIPAL_INVESTIGATOR) |
| Centennial Medical Group (CMG) | Columbia | Maryland | 21045 | David Luebbert, MD (PRINCIPAL_INVESTIGATOR) |
| SKY Integrative Medical Center | Ridgeland | Mississippi | 39157 | Bob Hutchins, MD (PRINCIPAL_INVESTIGATOR) |
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