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

NCT06282458 | Completed Phase 2 FDA Drug

• 1 other identifier: V2000101
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Muscle Loss; Obesity

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.

  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.

  Day 112

Secondary Outcomes (1)

• The percent change from baseline in total fat mass

  Day 112 and Day 196

Study Arms (3)

Semaglutide and Enobosarm 3 mg QD by mouth (E3G) daily

EXPERIMENTAL

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.

Drug: Enobosarm; Drug: Semaglutide

Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily

EXPERIMENTAL

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.

Drug: Enobosarm; Drug: Semaglutide

GLP-1 receptor agonist and Placebo QD by mouth (PG) daily

PLACEBO COMPARATOR

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.

Drug: Semaglutide

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 and Enobosarm 3 mg QD by mouth (E3G) daily; Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily

Semaglutide DRUG

Semaglutide for Chronic Weight Management

Also known as: Wegovy

GLP-1 receptor agonist and Placebo QD by mouth (PG) daily; Semaglutide and Enobosarm 3 mg QD by mouth (E3G) daily; Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), 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
• Aged ≥60 years
• For Female Subjects
• Menopausal status
• Be postmenopausal as defined by either:
• one year or more of amenorrhea
• surgical menopause with bilateral oophorectomy
• 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: 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
• If female partner of a study subject 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
• Female partner is menopausal as defined above

You may not qualify if:

• Known hypersensitivity or allergy to enobosarm or a GLP-1 receptor agonist
• Creatinine clearance \< 30 milliliter per minute (mL/min) as measured using the Cockcroft Gault formula (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 within 30 days prior to randomization
• Planned major surgery during course of the study
• 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.
• An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased medical risk
• 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
• 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

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (14)

Pinnacle Trials

Anniston, Alabama, 36207, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Universal Axom Clinical Research

Doral, Florida, 33122, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Pennington Biomedical

Baton Rouge, Louisiana, 70810, United States

Location

DelRicht Research - New Orleans

New Orleans, Louisiana, 70115, United States

Location

Centennial Medical Group (CMG)

Elkridge, Maryland, 21075, United States

Location

SKY Integrative Medical Center

Ridgeland, Mississippi, 39157, United States

Location

Clinvest Headlands LLC

Springfield, Missouri, 65807, United States

Location

Palm Research Center

Las Vegas, Nevada, 89119, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Clinical Trials of Texas, LLC DBA Flourish Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Obesity

Interventions

ostarine; semaglutide

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Study Design

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

Model Details: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study. The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: April 29, 2024
• Primary Completion: April 11, 2025
• Study Completion: August 22, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)