NCT07030868终止2 期
A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With Type-2 Diabetes (T2D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 84
- 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 treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.
Participation in the study will last about 11 months.
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-GN02:
- •Assigned male at birth
- •Assigned female at birth, who are of non-childbearing potential
- •Have type 2 diabetes
- •W8M-MC-CWMM:
- •Have a BMI ≥27 kilograms per square meter (kg/m²)
- •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-GN02:
- •Individuals who are of childbearing potential
- •Have a history of acute or chronic pancreatitis
- •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.
- •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 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
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
LY3549492 Low Dose
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 High Dose with Fast Titration
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 High Dose with Slow Titration
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline, Week 32
Percent change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and percent change was to be calculated relative to baseline.
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 32
次要结局
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline, Week 32)
- Change From Baseline in Body Weight(Baseline, Week 32)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 32)
- Pharmacokinetics (PK): Average Concentration of LY3549492(Week 0 and Week 24 (6-18 hours post-dose); Weeks 3, 9, 15, and 18 (1-3 hours post-dose); Weeks 6 and 21 (3-6 hours post-dose); Week 12 (1-6 hours post-dose); and Weeks 30 and 32 (pre-dose).)
- Change from Baseline in Body Weight(Baseline, Week 32)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 32)
- Pharmacokinetics (PK): Average Concentration of LY3549492(Week 32)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Baseline, Week 32)
研究者
研究点 (84)
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