| Eligibility |
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
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 within 2 years prior to screening, 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 exclusively with non-pharmacologic approaches (e.g., diet
and exercise) is not an exclusion.
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).
|
