Altus Research | Women's Health Studies
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About
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.
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Be postmenopausal as defined by either:
For Male Subjects
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
Exclusion criteria
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
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:
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).
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups, including a placebo group
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Central trial contact
Rodriguez; Barnette
Data sourced from clinicaltrials.gov
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