Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (PLATEAU)

April 21, 2026 updated by: Veru Inc.

PLATEAU: Phase 2b Proof-of-Concept Study to Evaluate the Effect on Total Body Weight, Physical Function and Safety of Enobosarm in Patients Treated With Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist, for Weight Reduction

The primary objective of this study is to assess the effect of enobosarm on total body weight

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, double-blind, and placebo-controlled study. Subjects will be randomized into two treatment arms (subcutaneous injectable semaglutide plus oral enobosarm 3mg dose group or subcutaneous injectable semaglutide plus placebo group) in a 1:1 fashion. All patients randomized into this study will initiate semaglutide subcutaneous injection therapy for weight reduction on Day 1 of this study.

The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 68 weeks (476 days). A safety follow up visit will occur approximately 30 days after last dose of study drug.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • DM Clinical Research - Phoenix
        • Principal Investigator:
          • Arvind Mahadevan, MD
        • Contact:
    • Florida
      • Doral, Florida, United States, 33166
        • Recruiting
        • DM Clinical Research - MIA
        • Contact:
        • Principal Investigator:
          • Noreen Shaaban, MD
      • Doral, Florida, United States, 33166
        • Recruiting
        • Universal Axon Clinical Research (Rovia - UACR)
        • Principal Investigator:
          • Luis Martinez
        • Contact:
      • Miami, Florida, United States, 33175
        • Recruiting
        • Paramo Health
        • Contact:
        • Principal Investigator:
          • Didiet Solano Perez
      • Miami, Florida, United States, 33176
        • Recruiting
        • IMIC Research a Rovia Clinical Research Company
        • Contact:
        • Principal Investigator:
          • Ramon Leon, MD
      • Miami, Florida, United States, 33176
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • UD Research
        • Contact:
        • Principal Investigator:
          • Marc Sonenshine, MD
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Pennington Biomedical Research Center
        • Contact:
        • Principal Investigator:
          • Stephen Heymsfield, MD
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Recruiting
        • Centennial Medical Group (CMG)
        • Contact:
        • Principal Investigator:
          • David Luebbert, MD
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • SKY Integrative Medical Center
        • Principal Investigator:
          • Bob Hutchins, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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. Be ≥65 years of age at the time of screening
    4. For Female Subjects Menopausal status

Be postmenopausal as defined by either:

  • one year or more of amenorrhea
  • surgical menopause with bilateral oophorectomy
  • Be premenopausal or perimenopausal with a negative pregnancy test.
  • If subject is of child bearing potential, the subject must agree to use acceptable methods of contraception: If female study participant 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: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, 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 study participant 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 study participant 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 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: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], 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. Medically indicated for use of semaglutide for weight reduction 6. Have BMI ≥35 7. Consents to continue treatment with semaglutide for up to 476 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 350lbs as per DXA requirements

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. 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)
  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 (the surgery poses a significant risk to patients life and requires general anesthesia) within 30 days prior to randomization
  5. 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
  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. A QTcF >450 ms for males and >450 ms for females is also exclusionary from this protocol.
  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 (except in cases of Gilbert's Syndrome)
  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. 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.
  19. Creatine kinase >1.5x ULN

  20. 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.
  21. Subjects with active or untreated malignancy within 5 years of screening (NOTE: treated non-melanoma skin cancers are allowable).
  22. Male subjects with a lifetime history of malignant prostate disease, such as prostate cancer.
  23. Male subjects with a PSA ≥4 ng/mL
  24. Patients with prior tendon rupture or those taking concomitant medications that increase the risk of tendon rupture (e.g., fluroquinoline antibiotics, bempedoic acid, or chronic use of systemic corticosteroids).
  25. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). NOTE: blood pressure may be retested as per the investigator criteria as needed.
  26. Patients with a resting heart rate ≥100 beats per minute. NOTE: heart rate may be retested as per the investigator criteria as needed.
  27. Patients that have received a GLP-1 Receptor Agonist (e.g., semaglutide) or a GIP/GLP-1 Receptor agonist (e.g., tirzepatide) within 12 months of Screening.
  28. Patients that wear foreign objects, at the discretion of the DXA technician, that cannot be removed at the time of DXA that could cause artifacts and decrease accuracy of exam, such as waist beads (e.g., for religious purposes).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcutaneous injectable semaglutide and oral enobosarm 3mg
Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD
Drug: Enobosarm
Enobosarm is an oral, new chemical entity class, SARM, that has demonstrated tissue-selective, dose-dependent improvement in body composition with increases in muscle mass and reduces fat mass, improves insulin resistance, has no masculinizing effects in women, has neutral prostate effects in men, and no increases in hematocrit. Increases in muscle mass have resulted in improvements in muscle strength and physical function.
Drug: Semaglutide (Wegovy) weekly injection
Semaglutide for Chronic Weight Management
Placebo Comparator: Subcutaneous injectable semaglutide and oral Placebo
Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo
Drug: Semaglutide (Wegovy) weekly injection
Semaglutide for Chronic Weight Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
Time Frame: Day 476
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
Day 476

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. The percent change from baseline in total fat mass
Time Frame: Day 476
1. The percent change from baseline in total fat mass
Day 476

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veru Inc.

Investigators

  • Study Chair: Barnette, Veru Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2000103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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