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QUALITY
CompletedPhase 2Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
A Phase 2 Dose-Finding and Proof-of-Concept Study to Evaluate the Effect on Body Composition and Safety of Enobosarm in Patients Treated With Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists for Chronic Weight Management
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
14
Recruiting sites
—
Enrollment
168
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Lean mass
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Subjects accepted for this study must:
1. Provide informed consent from the subject or the subject's legally authorized representative
2. Be able to communicate effectively with the study personnel
3. Aged ≥60 years
4. For Female Subjects
For Male Subjects
5. 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)
6. Medically indicated for use of GLP-1 receptor agonist for weight management.
7. Consents to be treated with GLP-1 receptor agonist for 84 days under this protocol.
8. Subject is willing to comply with the requirements of the protocol through the end of the study
9. The patient is able to swallow oral medications
10. The patient is able to complete the physical function (stair climb) assessment
11. Maximum weight at screening of 300lbs as per DEXA requirements
12. Complete a valid OSA assessment
Exclusion criteria
Any of the following conditions are cause for exclusion from the study:
1. Known hypersensitivity or allergy to enobosarm or a GLP-1 receptor agonist
2. 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)
3. Treatment with any investigational product within < 5 half-lives for each individual investigational product OR within 30 days prior to randomization
4. Major surgery within 30 days prior to randomization
5. Planned major surgery during course of the study
6. 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.
7. An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased medical risk
8. Concurrently participating in any other interventional or treatment clinical trial.
9. 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)
10. Baseline ALT or AST >3x upper limit of normal
11. Baseline total bilirubin levels > upper limit of normal
12. History of acute pancreatitis within one year of screening or history of chronic pancreatitis
13. Severe gastrointestinal disease, including gastroparesis
14. Major depressive disorder diagnosed within 2 years prior to screening (NOTE: a diagnosis of major depressive disorder ≥2 years prior to screening that is stably managed [with or without pharmacological intervention] without additional exclusionary history are not excluded from the study), history of other severe psychiatric disorder, including schizophrenia and bipolar disorder, any lifetime history of suicide attempt, or with suicidal ideation or behavior within 1 month prior to screening.
15. Patient Health Questionnaire score >15 or any suicidal ideation of type 4 or type 5 on the Columbia-Suicide Severity Rating Scale
16. Monogenic or syndrome obesity, and endocrine causes of obesity (such as untreated hypothyroidism or Cushing's syndrome), and obesity caused by medications that cause weight gain
17. Prior bariatric surgery or weight loss devices unless removed for ≥1 year prior to screening for this study.
18. Patients that are currently taking a GLP-1 receptor agonists or have taken a GLP-1 receptor agonists within one year prior to screening for this study. Patients may not resume treatment with GLP-1 receptor agonists until after the 30-day follow-up visit.
19. Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed with antidiabetic medication or non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion as long as other study criteria are met and the patient has not progressed to a diagnosis of diabetes.
20. Creatine kinase >ULN
21. Any condition that is exclusionary for use of semaglutide (generally WEGOVY) in the patient. See the WEGOVY Prescribing Information. The following contraindications are listed in the WEGOVY prescribing information:
1. Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
2. Known hypersensitivity to semaglutide or any of the excipients in WEGOVY
22. Subjects with active or untreated malignancy within 5 years of screening (NOTE:
treated non-melanoma skin cancers are allowable).
23. Male subjects with a lifetime history of malignant prostate disease, such as prostate cancer.
24. Male subjects with a PSA ≥4 ng/mL
25. Patients with prior tendon rupture or those taking concomitant medications that increase the risk of tendon rupture (e.g., fluroquinoline antibiotics, bempedoic acid, or corticosteroids).
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Weight & body composition
2 endpointsThe primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.
Time frame:Day 112
Lean mass
percent change from baseline, improvement
The percent change from baseline in total fat mass
Time frame:Day 112 and Day 196
Total fat mass
percent change from baseline, improvement
Publications (10)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The New England journal of medicine2025 Sep 18PMID40934115doi:10.1056/NEJMoa2500969via pubmed acronym asset candidate
- Lancet (London, England)2025 May 3PMID40169145doi:10.1016/S0140-6736(25)00509-4via pubmed acronym asset candidate
- ESC heart failure2025 Feb (month)PMID38806171doi:10.1002/ehf2.14857via pubmed acronym asset candidate
Strategies for minimizing muscle loss during use of incretin-mimetic drugs for treatment of obesity.
Obesity reviews : an official journal of the International Association for the Study of Obesity2025 Jan (month)PMID39295512doi:10.1111/obr.13841via pubmed acronym asset candidate- Drugs & aging2024 Nov (month)PMID39514148doi:10.1007/s40266-024-01150-9via pubmed acronym asset candidate
- Diabetes, obesity & metabolism2024 Mar (month)PMID38016699doi:10.1111/dom.15386via pubmed acronym asset candidate
- Diabetes, obesity & metabolism2023 Aug (month)PMID37055715doi:10.1111/dom.15077via pubmed acronym asset candidate
- Diabetes, obesity & metabolism2023 Jan (month)PMID36254579doi:10.1111/dom.14863via pubmed acronym asset candidate
- Frontiers in endocrinology2021 (year)PMID34248838doi:10.3389/fendo.2021.645617via pubmed acronym asset candidate
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.