NCT06683508已完成2 期
A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3549492 Once Daily Compared With Placebo in Adult Participants With Obesity or Overweight
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 97
- 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 evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.
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-GN01:
- •Assigned male at birth
- •Assigned female at birth, who are of non-childbearing potential
- •W8M-MC-CWMM:
- •Have a BMI of
- •≥ 30 kilograms per square meter (kg/m²) or
- •≥ 27 kg/m² and < 30 kg/m² with at least one 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-GN01:
- •Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
- •Have a history of acute or chronic pancreatitis
- •Have renal impairment
- •Individuals who are of childbearing potential
- •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 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
LY3549492 Dose 1
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 2
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 3
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 4
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 5
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo orally
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 36
次要结局
- Change from Baseline in Body Weight (kilograms)(Baseline, Week 36)
- Percentage of Participants who Achieve ≥5% Body Weight Reduction(Baseline, Week 36)
- Percentage of Participants who Achieve ≥10% Body Weight Reduction(Baseline, Week 36)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 36)
- Pharmacokinetics (PK): Average Concentration of LY3549492(Week 36)
研究者
研究点 (97)
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