CTRI/2023/11/060209进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared with Placebo in Adult Participants with Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
Eli Lilly and Company India Pvt Ltd12 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年12月15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
- 1,500
- 试验地点
- 12
- 主要终点
- Mean Percent Change from Baseline in Body Weight
研究概览
简要总结
This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 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 BMI ≥27.0 kg/m²
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- •Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of: either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding DPP-4i or GLP-1 RA).
排除标准
- •Have Type 1 Diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- •Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- •Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti- vascular endothelial growth factor inhibitors).
- •Have family (first-degree relative) or personal history of MTC or MEN2 syndrome.
- •Have had a history of chronic or acute pancreatitis.
结局指标
主要结局
Mean Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 72
次要结局
- 1. Mean Change from Baseline in Waist Circumference(2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) %)
研究者
研究点 (12)
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