Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 … (NCT06282458) | Clinical Trial Compass
CompletedPhase 2
Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
United States168 participantsStarted 2024-04-29
Plain-language 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.
Who can participate
Age range60 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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
✓. Documented evidence of obesity (BMI ≥30 or ≥27 with the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
✓. Medically indicated for use of GLP-1 receptor agonist for weight management.
✓. Consents to be treated with GLP-1 receptor agonist for 84 days under this protocol.
✓. Subject is willing to comply with the requirements of the protocol through the end of the study
Exclusion criteria
✕. 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
What they're measuring
1
The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.