Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in P… (NCT07446998) | Clinical Trial Compass
RecruitingPhase 2
Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
United States200 participantsStarted 2026-03-26
Plain-language summary
The primary objective of this study is to assess the effect of enobosarm on total body weight
Who can participate
Age range
65 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
. 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. A QTcF \>450 ms for males and \>450 ms for females is also exclusionary from this protocol.
. Concurrently participating in any other interventional or treatment clinical trial.