Actively Recruiting
Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
Led by Veru Inc. · Updated on 2026-04-22
200
Participants Needed
10
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess the effect of enobosarm on total body weight
CONDITIONS
Official Title
Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent or have consent from a legally authorized representative
- Be able to communicate effectively with study staff
- Be 65 years of age or older at screening
- For females: be postmenopausal or have a negative pregnancy test if premenopausal or perimenopausal
- Agree to use acceptable contraception if of childbearing potential or have a partner of childbearing potential
- Medically indicated for semaglutide use for weight reduction
- Have a body mass index (BMI) of 35 or higher
- Agree to continue semaglutide treatment for up to 476 days
- Willing to comply with study requirements through the end of the study
- Able to swallow oral medications
- Able to complete physical function (stair climb) assessments
- Have a maximum weight of 350 lbs at screening per DXA requirements
You will not qualify if you...
- Known allergy or hypersensitivity to enobosarm or GLP-1 receptor agonists
- Estimated kidney function (eGFR) below 30 mL/min/1.73 m2
- Treatment with investigational drugs within 5 half-lives or 30 days before randomization
- Major surgery within 30 days before randomization or planned during the study
- Planned cosmetic surgery affecting body composition
- Use of certain androgenic or antiandrogenic medications without required washout
- Abnormal ECG posing increased medical risk or QTcF over 450 ms
- Participation in other interventional clinical trials
- Pre-existing liver diseases or abnormal liver function tests beyond set limits
- History of acute or chronic pancreatitis
- Severe gastrointestinal diseases like gastroparesis
- Recent major depressive disorder or serious psychiatric disorders
- High scores on depression or suicide risk assessments
- Genetic or endocrine causes of obesity or medication-induced obesity
- Prior bariatric surgery or weight loss devices unless removed over a year ago
- Diabetes requiring antidiabetic drugs or HbA1c 6.5% or higher
- Elevated creatine kinase levels above 1.5 times normal
- Contraindications for semaglutide use including certain cancers and allergies
- Active or untreated cancer within 5 years (except treated non-melanoma skin cancer)
- History of malignant prostate disease or high PSA in males
- History of tendon rupture or medications increasing tendon rupture risk
- Uncontrolled high blood pressure or resting heart rate over 100 bpm
- Use of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists within 12 months
- Presence of non-removable foreign objects affecting DXA scan accuracy (e.g., waist beads)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
DM Clinical Research - Phoenix
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
DM Clinical Research - MIA
Doral, Florida, United States, 33166
Actively Recruiting
3
Universal Axon Clinical Research (Rovia - UACR)
Doral, Florida, United States, 33166
Actively Recruiting
4
Paramo Health
Miami, Florida, United States, 33175
Actively Recruiting
5
IMIC Research a Rovia Clinical Research Company
Miami, Florida, United States, 33176
Actively Recruiting
6
Paramo Health
Miami, Florida, United States, 33176
Actively Recruiting
7
UD Research
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
9
Centennial Medical Group (CMG)
Columbia, Maryland, United States, 21045
Actively Recruiting
10
SKY Integrative Medical Center
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
Research Team
G
Gary Barnette
CONTACT
D
Domingo Rodriguez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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