A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 89
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.
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
- 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
- •W8M-MC-LAA1
- •Are males and females who agree to abide by the reproductive and contraceptive requirements
- •W8M-MC-CWMM:
- •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
- •W8M-MC-LAA1
- •Have any prior diagnosis of diabetes mellitus except gestational diabetes.
- •Have any of the following cardiovascular conditions within 6 months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure (CHF).
- •Have a history of acute or chronic pancreatitis.
- •Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
- •W8M-MC-CWMM
- •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 a history of symptomatic gallbladder disease within the past 2 years
- •Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- •Have a lifetime history of suicide attempts.
研究组 & 干预措施
LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
干预措施: LY3841136 (Drug)
LY3841136 Dose 2
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 3
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 4
Participants will receive LY3841136 SC.
干预措施: LY3841136 (Drug)
LY3841136 Dose 5
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 6
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
Placebo
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 48
次要结局
- Change from Baseline in Body Weight(Baseline, Week 48)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 48)
- PK: Maximum Concentration (Cmax) of LY3841136(Baseline to Week 48)
- Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136(Baseline to Week 48)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Baseline to Week 48)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline to Week 48)