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Muscle LossPhase 2QUALITYNCT06282458

Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt

A Phase 2 study testing Enobosarm and Semaglutide in people with Muscle Loss and Obesity, run by Veru Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Loss, Obesity
What is being tested?
Enobosarm and Semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
14 sitesUnited States
Study dates
29 Apr 2024to 22 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 60 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, 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
  • Aged ≥60 years
  • For Female Subjects
  • Menopausal status
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  • 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
  • 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
  • The patient is able to swallow oral medications
  • The patient is able to complete the physical function (stair climb) assessment
  • Maximum weight at screening of 300lbs as per DEXA requirements
  • Complete a valid OSA assessment

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
  • 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
  • Planned major surgery during course of the study
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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
  • 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
  • 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.
  • 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.
  • 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 >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 corticosteroids).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Pinnacle Trials

    Anniston, Alabama, 36207

  • Pennington Biomedical

    Baton Rouge, Louisiana, 70810

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Universal Axom Clinical Research

    Doral, Florida, 33122

  • Centennial Medical Group (CMG)

    Elkridge, Maryland, 21075

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Altus Research

    Lake Worth, Florida, 33461

  • Palm Research Center

    Las Vegas, Nevada, 89119

  • MARC Research Center

    Louisville, Kentucky, 40213

  • DelRicht Research - New Orleans

    New Orleans, Louisiana, 70115

  • SKY Integrative Medical Center

    Ridgeland, Mississippi, 39157

  • Clinical Trials of Texas, LLC DBA Flourish Research

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Clinvest Headlands LLC

    Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled, dose-assessing study. Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study.

The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow up visit will occur approximately 30 days after last dose of study drug.

The safety of enobosarm compared to the placebo control will be evaluated by an Independent Data Monitoring Committee (IDMC).

Conditions
Muscle Loss, Obesity
Being tested
Enobosarm, Semaglutide
Medical subject headings
Muscular Atrophy, Obesity

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.

  • SemaglutideDrug

    Also called Wegovy

    Semaglutide for Chronic Weight Management

Study groups in NCT06282458
Study groupRoleWhat they receive
Semaglutide and Enobosarm 3 mg QD by mouth (E3G) dailyExperimentalApproximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 3 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 3 mg enobosarm QD by mouth and will discontinue the semaglutide.
Receives: Drug: Enobosarm; Drug: Semaglutide
Semaglutide and Enobosarm 6 mg QD by mouth (E6G) dailyExperimentalApproximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 6 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 6 mg enobosarm QD by mouth and will discontinue the semaglutide.
Receives: Drug: Enobosarm; Drug: Semaglutide
GLP-1 receptor agonist and Placebo QD by mouth (PG) dailyPlacebo comparatorApproximately 50 subjects will be dosed with semaglutide injected once-weekly and placebo QD by mouth (PG) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive placebo QD by mouth (PG) and will discontinue the semaglutide.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.

    To determine the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists (percent change in total lean mass) at 112 days.

    Measured: Day 112

Secondary outcomes (1)

  1. The percent change from baseline in total fat mass

    The percent change from baseline in total fat mass from Day 112 and at Day 196

    Measured: Day 112 and Day 196

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start29 Apr 2024
  3. Primary completion11 Apr 2025
  4. Study completion22 Aug 2025

Resources

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
Model description
Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study. The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282458
Sponsor's protocol ID
V2000101
Acronym
QUALITY
Status last verified
Sep 2025
First submitted
20 Feb 2024
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enobosarm and Semaglutide in people with Muscle Loss and Obesity, run by Veru Inc. at 14 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 23 inclusion and 30 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: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. (time frame: Day 112). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282458.

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 17 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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