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Tests treatment safety and results for Obesity & Overweight
Official title Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
ClinicalTrials.gov ID: NCT07446998
What this study is testing
What is Enobosarm?
Enobosarm is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity & overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to assess the effect of enobosarm on total body weight
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100
You may be able to join if
- people 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 people Menopausal status Be postmenopausal as defined by either:
You likely can't join if
- 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)...
- 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...
See the full eligibility criteria
- people 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 people Menopausal status Be postmenopausal as defined by either:
- 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...
- 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...
- 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
- Testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds...
- 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 treatment 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]...
- 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...
- 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.
- people with active or untreated malignancy within 5 years of screening (NOTE: treated non-melanoma skin cancers are allowable).
- Male people with a lifetime history of malignant prostate disease, such as prostate cancer.
- Male people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Doral, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Baton Rouge, Louisiana, United States
- Columbia, Maryland, United States
- Ridgeland, Mississippi, United States
- New York, New York, United States
- Fayetteville, North Carolina, United States
- Irving, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Doral, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Baton Rouge, Louisiana, United States; Columbia, Maryland, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.