CTRI/2023/11/059873进行中（未招募）3 期
A Master Protocol to Investigate the Efficacy and Safety of LY3437943Once Weekly in Participants without Type 2 Diabetes who have Obesity orOverweight: A Randomized, Double-Blind, Placebo-Controlled Trial(TRIUMPH-1)
Eli Lilly and Company India Pvt Ltd14 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2023年12月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,100
- 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 who have obesity or overweight (J1I-MC-GZBJ master protocol). This 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 body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following: hypertension, dyslipidemia obstructive sleep apnea, or cardiovascular disease
- •History of at least one unsuccessful dietary effort to reduce 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 diabetes mellitus.
- •Have 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
- 1. Change from Baseline in Body Mass Index (BMI)(2. Change from Baseline in Waist Circumference)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 80)
研究者
研究点 (14)
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