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

NCT07446998 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: V2000103U1111-1343-2062
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Obesity & Overweight; Mobility Disability; HOMA-IR

Outcome Measures

Primary Outcomes (1)

• To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.

  To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.

  Day 476

Secondary Outcomes (1)

• 1. The percent change from baseline in total fat mass

  Day 476

Study Arms (2)

Subcutaneous injectable semaglutide and oral enobosarm 3mg

EXPERIMENTAL

Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD

Drug: Enobosarm; Drug: Semaglutide (Wegovy) weekly injection

Subcutaneous injectable semaglutide and oral Placebo

PLACEBO COMPARATOR

Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo

Drug: Semaglutide (Wegovy) weekly injection

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.

Subcutaneous injectable semaglutide and oral enobosarm 3mg

Semaglutide (Wegovy) weekly injection DRUG

Semaglutide for Chronic Weight Management

Subcutaneous injectable semaglutide and oral Placebo; Subcutaneous injectable semaglutide and oral enobosarm 3mg

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects accepted for this study must:
• Provide informed consent from the subject or the subject's legally authorized representative
• Be able to communicate effectively with the study personnel
• Be ≥65 years of age at the time of screening
• For Female Subjects Menopausal status
• Be postmenopausal as defined by either:
• one year or more of amenorrhea
• surgical menopause with bilateral oophorectomy
• Be premenopausal or perimenopausal with a negative pregnancy test.
• If subject is of child bearing potential, the subject must agree to use acceptable methods of contraception: If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 30 days following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
• If female study participant has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
• If female study participant has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used For Male Subjects
• Subject must agree to use acceptable methods of contraception:
• If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 30 days following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
• If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used

You may not qualify if:

• Known hypersensitivity or allergy to enobosarm or a GLP-1 receptor agonist
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as measured using the chronic kidney disease-epidemiology collaboration (CKD-EPI) calculation (patients with mild and moderate renal failure are not excluded from participation in this study)
• Treatment with any investigational product within \< 5 half-lives for each individual investigational product OR within 30 days prior to randomization
• Major surgery (the surgery poses a significant risk to patients life and requires general anesthesia) within 30 days prior to randomization
• Planned major surgery during the course of the study or any cosmetic surgery potentially impacting body composition, e.g., liposuction, implants, or removal of any current implants
• Testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), myostatin inhibitors, apelin receptor agonists, or antiandrogens (flutamide, bicalutamide, abiraterone, enzalutamide, apalutamide, or darolutamide).
• Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the Medical Monitor) or any other androgenic agent.
• Concurrently participating in any other interventional or treatment clinical trial.
• Pre-existing liver disease (hepatitis B, uncontrolled hepatitis A, hepatitis C, autoimmune hepatitis, liver cancer, alcohol-associated cirrhosis, alcohol-associated hepatitis, alcohol-associated fatty liver)
• Baseline ALT or AST \>3x upper limit of normal
• Baseline total bilirubin levels \>upper limit of normal (except in cases of Gilbert's Syndrome)
• History of acute pancreatitis within one year of screening or history of chronic pancreatitis
• Severe gastrointestinal disease, including gastroparesis
• Patient Health Questionnaire score \>15 or any suicidal ideation of type 4 or type 5 on the Columbia-Suicide Severity Rating Scale
• Monogenic or syndrome obesity, and endocrine causes of obesity (such as untreated hypothyroidism or Cushing's syndrome), and obesity caused by medications that cause weight gain

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (14)

DM Clinical Research - Phoenix

Phoenix, Arizona, 85012, United States

RECRUITING

DM Clinical Research - MIA

Doral, Florida, 33166, United States

RECRUITING

Universal Axon Clinical Research (Rovia - UACR)

Doral, Florida, 33166, United States

RECRUITING

Paramo Health

Miami, Florida, 33175, United States

RECRUITING

IMIC Research a Rovia Clinical Research Company

Miami, Florida, 33176, United States

RECRUITING

Paramo Health

Miami, Florida, 33176, United States

RECRUITING

UD Research

Atlanta, Georgia, 30342, United States

WITHDRAWN

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Centennial Medical Group (CMG)

Columbia, Maryland, 21045, United States

RECRUITING

SKY Integrative Medical Center

Ridgeland, Mississippi, 39157, United States

RECRUITING

ALSA Research

New York, New York, 10016, United States

RECRUITING

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States

RECRUITING

DM Clinical - Dallas

Irving, Texas, 75061, United States

RECRUITING

DM Clinical - Seattle

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

ostarine; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Central Study Contacts

Gary Barnette

CONTACT

8006069382; veruclinicaltrials@verupharma.com

Domingo Rodriguez

CONTACT

8006069382; veruclinicaltrials@verupharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)