CTRI/2023/10/058324招募中3 期
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants with Type 2 Diabetes Mellitus who have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-2)
Eli Lilly and Company India Pvt Ltd14 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年11月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes who have obesity or overweight (J1I-MC-GZBK master protocol). The study will last about 89 weeks and will include up to 24 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m²)
- •Have Type 2 Diabetes (T2D)
- •Are on stable treatment for T2D for at least 90 days
- •Have a history of at least one unsuccessful dietary effort to lose body weight.
排除标准
- •Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
- •Have a prior or planned surgical treatment for obesity
- •Have Type 1 diabetes.
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had pancreatitis.
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 80
次要结局
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 80)
- 1. Change from Baseline in Body Mass Index (BMI)(2. Change from Baseline in Waist Circumference)
研究者
研究点 (14)
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