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

Inclusion Criteria:

Subjects accepted for this study must:

1. Provide informed consent from the subject or the subject's legally authorizedrepresentative

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 ofcontraception from the time of the first administration of study medicationuntil 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 usedwith spermicidal foam/gel/film/cream/suppository}, the female partner uses oralcontraceptives (combination estrogen/progesterone pills), injectableprogesterone or subdermal implants and a barrier method (condom used withspermicidal 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 spermicidalfoam/gel/film/cream/suppository) should also be used

• If female partner of a study subject has undergone documented placement of anintrauterine 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 oneweight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, ordyslipidemia)

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 endof 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 theCockcroft Gault formula (patients with mild and moderate renal failure are notexcluded from participation in this study)

3. Treatment with any investigational product within < 5 half-lives for each individualinvestigational 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 asdehydroepiandrosterone, androstenedione, and other androgenic compounds, includingherbals), 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 androgenicagent.

7. An abnormal ECG result which, based on the investigator's clinical judgment, wouldplace 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-associatedhepatitis, 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 chronicpancreatitis

13. Severe gastrointestinal disease, including gastroparesis

14. Major depressive disorder diagnosed within 2 years prior to screening (NOTE: adiagnosis of major depressive disorder ≥2 years prior to screening that is stablymanaged [with or without pharmacological intervention] without additionalexclusionary history are not excluded from the study), history of other severepsychiatric disorder, including schizophrenia and bipolar disorder, any lifetimehistory of suicide attempt, or with suicidal ideation or behavior within 1 monthprior to screening.

15. Patient Health Questionnaire score >15 or any suicidal ideation of type 4 or type 5on the Columbia-Suicide Severity Rating Scale

16. Monogenic or syndrome obesity, and endocrine causes of obesity (such as untreatedhypothyroidism or Cushing's syndrome), and obesity caused by medications that causeweight gain

17. Prior bariatric surgery or weight loss devices unless removed for ≥1 year prior toscreening for this study.

18. Patients that are currently taking a GLP-1 receptor agonists or have taken a GLP-1receptor agonists within one year prior to screening for this study. Patients maynot resume treatment with GLP-1 receptor agonists until after the 30-day follow-upvisit.

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-diabeticdrug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impairedglucose tolerance managed with antidiabetic medication or non-pharmacologicapproaches (e.g., diet and exercise) is not an exclusion as long as other studycriteria 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 thepatient. See the WEGOVY Prescribing Information. The following contraindications arelisted in the WEGOVY prescribing information:

22. Personal or family history of medullary thyroid carcinoma or in patients withMultiple Endocrine Neoplasia syndrome type 2

23. Known hypersensitivity to semaglutide or any of the excipients in WEGOVY

24. Subjects with active or untreated malignancy within 5 years of screening (NOTE: treated non-melanoma skin cancers are allowable).

25. Male subjects with a lifetime history of malignant prostate disease, such asprostate cancer.

26. Male subjects with a PSA ≥4 ng/mL

27. Patients with prior tendon rupture or those taking concomitant medications thatincrease the risk of tendon rupture (e.g., fluroquinoline antibiotics, bempedoicacid, or corticosteroids).