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QUALITY

CompletedPhase 2

Dose-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

Veru Inc.

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

NCT IDNCT06282458
Org study IDV2000101

Timeline

Milestones

Study first posted2024-02-28actual
Study start2024-04-29actual
Primary completion2025-04-11actual
Study completion2025-08-22actual
Last update posted2025-09-17actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age60 Years
Maximum age100 Years
SexAll
Healthy volunteersAccepted

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

Menopausal status
Be postmenopausal as defined by either:
one year or more of amenorrhea
surgical menopause with bilateral oophorectomy

For Male Subjects

Subject must agree to use acceptable methods of contraception:
If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 30 days following administration of the last dose of study medication. Acceptable methods of contraception are as follows: surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
Female partner is menopausal as defined above

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 endpoints
Primary/protocol endpoint

The 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

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.