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

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

Jun 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 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 ]

Central Contacts

• Gary Barnette
  8006069382
  [email protected]
• Domingo Rodriguez
  8006069382
  [email protected]

Locations (14)

Find similar trials in Phoenix, AZ

Related Studies

• Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial
  Not Yet Recruiting · Toivoa Inc · Dover, Delaware
• Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching
  Not Yet Recruiting · Toivoa Inc · Dover, Delaware
• Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
  Recruiting · University of Rochester · Rochester, New York
• Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
  Recruiting · Kennesaw State University · Kennesaw, Georgia