NCT07446998进行中（未招募）2 期
PLATEAU: Phase 2b Proof-of-Concept Study to Evaluate the Effect on Total Body Weight, Physical Function and Safety of Enobosarm in Patients Treated With Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist, for Weight Reduction
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Veru Inc.
- 入组人数
- 239
- 试验地点
- 27
- 主要终点
- To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
研究概览
简要总结
The primary objective of this study is to assess the effect of enobosarm on total body weight
详细描述
This study is a multicenter, randomized, double-blind, and placebo-controlled study. Subjects will be randomized into two treatment arms (subcutaneous injectable semaglutide plus oral enobosarm 3mg dose group or subcutaneous injectable semaglutide plus placebo group) in a 1:1 fashion. All patients randomized into this study will initiate semaglutide subcutaneous injection therapy for weight reduction on Day 1 of this study.
The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 68 weeks (476 days). A safety follow up visit will occur approximately 30 days after last dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Be ≥65 years of age at the time of screening
- •For Female Subjects 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 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: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, 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 study participant 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 study participant 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 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: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], 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. Medically indicated for use of semaglutide for weight reduction
- •Have BMI ≥35
- •Consents to continue treatment with semaglutide for up to 476 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 10.The patient is able to complete the physical function (stair climb) assessment 11.Maximum weight at screening of 350lbs as per DXA requirements
排除标准
- •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 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 (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, 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. A QTcF >450 ms for males and >460 ms for females is also exclusionary from this protocol.
- •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 (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] 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.
- •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 >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.
- •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 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 purposes).
研究组 & 干预措施
Subcutaneous injectable semaglutide and oral Placebo
Placebo Comparator
Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo
干预措施: Semaglutide (Wegovy) weekly injection (Drug)
Subcutaneous injectable semaglutide and oral enobosarm 3mg
Experimental
Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD
干预措施: Semaglutide (Wegovy) weekly injection (Drug)
Subcutaneous injectable semaglutide and oral enobosarm 3mg
Experimental
Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD
干预措施: Enobosarm (Drug)
结局指标
主要结局
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
时间窗: Day 476
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
次要结局
- 1. The percent change from baseline in total fat mass(Day 476)
研究者
研究点 (27)
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