NCT07729332尚未招募4 期
Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1-based Therapy Discontinuation
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent change in body weight
研究概览
简要总结
This study will compare the effect of orforglipron and phentermine on weight maintenance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years at screening
- •History of BMI ≥30 kg/m²
- •Current or recent (within 8 weeks) treatment with injectable semaglutide, tirzepatide, or similar GLP-1 based medication
- •Achieved ≥10% body weight loss since initiation of injectable semaglutide, tirzepatide or similar GLP-1 based medication
- •Willing to participate in the study after reviewing study infographic and confirming understanding of randomization and study procedures
- •Ability to understand and the willingness to sign a written informed consent document
- •Residence in Massachusetts
排除标准
- •Current type 2 diabetes mellitus
- •Recent or planned surgical obesity treatment (bariatric surgery >1 year prior to GLP-1 initiation allowed)
- •Pregnancy, intent to become pregnant, or current breastfeeding (participants of childbearing potential must have a negative pregnancy test at baseline)
- •History of pancreatitis
- •History of transplanted organ (corneal transplants permitted) or awaiting organ transplant
- •Obesity induced by endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome)
- •History of significant active or unstable major depressive disorder or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, serious mood or anxiety disorder) within the past 2 years
- •Any history of a suicide attempt
- •Systemic glucocorticoid therapy >2 weeks within the prior 3 months, or anticipated need within the next 12 months
- •Use of medications known to cause significant weight gain (e.g., olanzapine, lithium) within the last 3 months.
- •Quit using nicotine-containing products less than 6 months prior to baseline visit or intention to quit use in the next year
- •Current use strong CYP3A4 inducer medications (which may include: phenytoin, carbamazepine, phenobarbital, primidone, lumacaftor, midostaurin, and pentobarbital).
- •Use of prescription or over-the-counter weight loss medications within the last 3 months, other than semaglutide, tirzepatide, or other injectable GLP-1 medication
- •Chronic kidney disease stage 3b or lower (eGFR <45 mL/min/1.73m²)
- •Acute hepatitis or liver failure/cirrhosis
- •Known contraindications to phentermine:
- •History of coronary artery, cerebrovascular or peripheral arterial disease including myocardial infarction, unstable angina, revascularization, stroke/TIA, carotid intervention, claudication
- •Poorly-controlled blood pressure (>149/94) or elevated heart rate (>110 bpm)
- •History of cardiac arrhythmia
- •History of valvular heart disease
- •Congestive heart failure (any history or current)
- •Active / currently-treated hyperthyroidism (thyroid function screening required if pulse>100)
- •History of glaucoma or been told by an ophthalmologist that you are at high risk for glaucoma
- •Heavy alcohol use within the last 6 months (men: more than 4 drinks on any day or more than 14 drinks per week; women: more than 3 drinks on any day or more than 7 drinks per week)
- •History of substance use disorder or active use of illicit substances within the last 12 months. Tetrahydrocannabinol (THC)-containing products will not be considered an illicit substance. (e.g., uncontrolled hypertension, active/unstable cardiovascular disease, arrhythmia, hyperthyroidism [thyroid function screening required if pulse>100], glaucoma, history of substance use disorder
- •16. Use of any stimulant medications.
- •Known contraindication to orforglipron (e.g., personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2).
- •18. Any condition (e.g., drug or alcohol abuse, diagnosed eating disorder, other psychiatric disorder) that in the investigator's opinion may preclude protocol compliance
结局指标
主要结局
Percent change in body weight
时间窗: 6 months
Percent change in body weight from randomization to 6 months
次要结局
未报告次要终点
研究者
Deborah Wexler, MD
Associate Professor of Medicine, Harvard Medical School
Massachusetts General Hospital
研究点 (1)
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