Obesity & OverweightPhase 2PLATEAUNCT07446998
Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
A Phase 2 study testing Enobosarm and Semaglutide (Wegovy) weekly injection in people with Obesity & Overweight and Mobility Disability, run by Veru Inc. at 13 sites in United States.
Trial summary
The primary objective of this study is to assess the effect of enobosarm on total body weight Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Obesity & Overweight, Mobility Disability, HOMA-IR
- What is being tested?
- Enobosarm and Semaglutide (Wegovy) weekly injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 13 sitesUnited States
- Study dates
- 26 Mar 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects accepted for this study must:
- 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
- Be postmenopausal as defined by either:
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- 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
Who cannot join
- Any of the following conditions are cause for exclusion from the study:
- 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
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- 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 >460 ms for females is also exclusionary from this protocol.
- Concurrently participating in any other interventional or treatment clinical trial.
- 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)
- Baseline ALT or AST >3x upper limit of normal
- Baseline total bilirubin levels >upper limit of normal (except in cases of Gilbert's Syndrome)
- History of acute pancreatitis within one year of screening or history of chronic pancreatitis
- Severe gastrointestinal disease, including gastroparesis
- 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.
- Patient Health Questionnaire score >15 or any suicidal ideation of type 4 or type 5 on the Columbia-Suicide Severity Rating Scale
- 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
- Prior bariatric surgery or weight loss devices unless removed for ≥1 year prior to screening for this study.
- 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.
- Creatine kinase >1.5x ULN
- 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:
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- Known hypersensitivity to semaglutide or any of the excipients in WEGOVY.
- Subjects with active or untreated malignancy within 5 years of screening (NOTE:
- treated non-melanoma skin cancers are allowable).
- Male subjects with a lifetime history of malignant prostate disease, such as prostate cancer.
- Male subjects with a PSA ≥4 ng/mL
- 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).
- 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.
- Patients with a resting heart rate ≥100 beats per minute. NOTE: heart rate may be retested as per the investigator criteria as needed.
- 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.
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Centennial Medical Group (CMG)
Columbia, Maryland, 21045
DM Clinical Research - MIA
Doral, Florida, 33166
Universal Axon Clinical Research (Rovia - UACR)
Doral, Florida, 33166
Coastal Research Institute, LLC
Fayetteville, North Carolina, 28304
DM Clinical - Dallas
Irving, Texas, 75061
Paramo Health
Miami, Florida, 33175
IMIC Research a Rovia Clinical Research Company
Miami, Florida, 33176
Paramo Health
Miami, Florida, 33176
ALSA Research
New York, New York, 10016
DM Clinical Research - Phoenix
Phoenix, Arizona, 85012
SKY Integrative Medical Center
Ridgeland, Mississippi, 39157
DM Clinical - Seattle
Seattle, Washington, 98122
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity & Overweight, Mobility Disability, HOMA-IR
- Being tested
- Enobosarm, Semaglutide (Wegovy) weekly injection
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnobosarmDrug
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.
Semaglutide (Wegovy) weekly injectionDrug
Semaglutide for Chronic Weight Management
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous injectable semaglutide and oral enobosarm 3mg | Experimental | Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD Receives: Drug: Enobosarm; Drug: Semaglutide (Wegovy) weekly injection |
| Subcutaneous injectable semaglutide and oral Placebo | Placebo comparator | Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo Receives: Drug: Semaglutide (Wegovy) weekly injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
Measured: Day 476
Secondary outcomes (1)
1. The percent change from baseline in total fat mass
- The percent change from baseline in total fat mass
Measured: Day 476
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start26 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barnette, Study chair, Veru Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446998
- Sponsor's protocol ID
- V2000103
- Other IDs
- U1111-1343-2062
- Acronym
- PLATEAU
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446998
- Acronym / sponsor ID
- PLATEAU / V2000103
- Conditions
- Obesity & Overweight, Mobility Disability, HOMA-IR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Veru Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the effect of enobosarm on total body weight
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous injectable semaglutide and oral enobosarm 3mg | Experimental | Drug: Enobosarm, Drug: Semaglutide (Wegovy) weekly injectionApproximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD |
| Subcutaneous injectable semaglutide and oral Placebo | Placebo comparator | Drug: Semaglutide (Wegovy) weekly injectionApproximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Subjects accepted for this study must:
- 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)
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnobosarmEnobosarm 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 | Subcutaneous injectable semaglutide and oral enobosarm 3mg |
| Semaglutide (Wegovy) weekly injectionSemaglutide for Chronic Weight Management | Drug | Subcutaneous injectable semaglutide and oral Placebo, Subcutaneous injectable semaglutide and oral enobosarm 3mg |
Primary outcome
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.
1 secondary outcome
1. The percent change from baseline in total fat mass
Time frame: Day 476
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barnette study chair
Veru Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enobosarm and Semaglutide (Wegovy) weekly injection in people with Obesity & Overweight and Mobility Disability, run by Veru Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone. (time frame: Day 476). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.