The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Percent body weight change at 12 weeks
研究概览
简要总结
The study compares the effectiveness of treatment options for weight management after discontinuing semaglutide and tirzepatide. The primary outcome is absolute and percentage weight change at 12-weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Previous hx of BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- •Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months
- •At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound
- •Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason
- •Ability to provide informed consent prior to any trial-related activities
- •Able to read and write in English
排除标准
- •BMI <22 kg/m2
- •Previous surgical obesity treatment
- •Currently pregnant or intending to become pregnant during the study
- •Breastfeeding
- •History of seizures or epilepsy
- •Current opioid use or in acute opioid withdrawal
- •Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs
- •History of glaucoma
- •Uncontrolled hypertension
- •Severe renal impairment and/or Chronic kidney disease stage III or GFR <60
- •Acute hepatitis or liver failure
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- •Use of antipsychotic medications or opiod analgesics
- •Current or previous history of anorexia or bulimia nervosa
- •Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
- •Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use
- •Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine
- •Current use of beta blockers
- •Current use of depo shot (medroxyprogesterone acetate) for birth control
- •Current diagnosis of Cushing's disease or syndrome
- •Current use of Monoamine Oxidase Inhibitors (MAOIs)
- •Known hypersensitivity to bupropion, naltrexone, or metformin
- •Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
研究组 & 干预措施
WW Clinic + Meds v2
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
干预措施: Bupropion-Naltrexone-Metformin (Drug)
WW Clinic - No medications
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications.
干预措施: WW Clinic (Behavioral)
WW Clinic + Meds v1
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
干预措施: WW Clinic (Behavioral)
WW Clinic + Meds v1
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
干预措施: Bupropion-Naltrexone (Drug)
WW Clinic + Meds v2
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
干预措施: WW Clinic (Behavioral)
结局指标
主要结局
Percent body weight change at 12 weeks
时间窗: Baseline, 12 weeks
Measurement of weight using a bluetooth body weight scale
次要结局
- Change in body weight (in kg or pounds) at 12 weeks(Baseline, 12 weeks)
- Physical Activity and Sedentary Behavior(Baseline, 12 weeks)
- Dietary Intake(Baseline, 12 weeks)
- Habit/Automaticity(Baseline, 12 weeks)
- Hunger VAS (Visual Analogue Scale)(Baseline, 12 weeks)
- Impact on Quality of Life(Baseline, 12 weeks)
- Well-being(Baseline, 12 weeks)
- Body Appreciation(Baseline, 12 weeks)
- Self-Compassion(Baseline, 12 weeks)
- Weight Bias(Baseline, 12 weeks)
研究者
Kara Marlatt
Sr Director, Scientific Research
WW International Inc