A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,481
- 试验地点
- 56
- 主要终点
- Number of Participants Allocated to Each ISA
研究概览
简要总结
The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI)
- •≥30 kilogram/square meter (kg/m²), or
- •≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity
- •Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.
排除标准
- •Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
- •Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
- •Have poorly controlled hypertension.
- •Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- •Have any of the following cardiovascular conditions within 3 months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure.
- •Have a history of symptomatic gallbladder disease within the past 2 years.
- •Have a lifetime history of suicide attempts.
研究组 & 干预措施
LY3841136 Obesity ISA LAA1
Participants will receive LY3841136 or placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
LY3841136 Obesity ISA LAA2
Participants will receive LY3841136, tirzepatide and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
LY3549492 Obesity ISA GN01
Participants will receive LY3549492 or placebo orally.
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
LY3549492 Obesity ISA GN02
Participants will receive LY3549492 or placebo orally.
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
LY3549492 Obesity ISA GN01
Participants will receive LY3549492 or placebo orally.
Each ISA will detail the intervention specific analysis.
干预措施: LY3549492 (Drug)
LY3841136 Obesity ISA LAA2
Participants will receive LY3841136, tirzepatide and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: LY3841136 (Drug)
LY3841136 Obesity ISA LAA2
Participants will receive LY3841136, tirzepatide and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: Tirzepatide (Drug)
LY3305677 Obesity ISA OXA1
Participants will receive LY3305677 or placebo subcutaneously (SC).
Each ISA will detail the intervention specific analysis.
干预措施: LY3305677 (Drug)
Obesity ISA MC01
Participants will receive macupatide, eloralintide, and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
Obesity ISA MC01
Participants will receive macupatide, eloralintide, and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: LY3532226 (Drug)
LY3305677 Obesity ISA OXA1
Participants will receive LY3305677 or placebo subcutaneously (SC).
Each ISA will detail the intervention specific analysis.
干预措施: Placebo (Drug)
Obesity ISA MC01
Participants will receive macupatide, eloralintide, and placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: LY3841136 (Drug)
LY3841136 Obesity ISA LAA1
Participants will receive LY3841136 or placebo SC.
Each ISA will detail the intervention specific analysis.
干预措施: LY3841136 (Drug)
LY3549492 Obesity ISA GN02
Participants will receive LY3549492 or placebo orally.
Each ISA will detail the intervention specific analysis.
干预措施: LY3549492 (Drug)
结局指标
主要结局
Number of Participants Allocated to Each ISA
时间窗: Baseline to Week 6
Each ISA will detail the intervention specific analysis.
次要结局
未报告次要终点