The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition Trial)
概览
- 阶段
- 4 期
- 干预措施
- Bupropion-Naltrexone-Metformin
- 疾病 / 适应症
- Obesity
- 发起方
- WW International Inc
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Percent body weight change at 12 weeks
- 状态
- 已完成
- 最后更新
- 19天前
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.
研究者
Kara Marlatt
Sr Director, Scientific Research
WW International Inc
入排标准
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
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
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
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
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
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
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)