CTRI/2024/10/075621招募中3 期
A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared with Placebo in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Diet and Exercise Alone (TRANSCEND-T2D-1)
Eli Lilly Company (India) Pvt. Ltd.8 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年12月9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
- 480
- 试验地点
- 8
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c) (%)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
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 Type 2 Diabetes (T2D)
- •Have HbA1c between 7.0% to 9.5%
- •Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
- •Are of stable weight for at least 90 days prior to screening
- •Have a Body Mass Index (BMI) greater than 23.0 kilograms per meter squared.
排除标准
- •Have Type 1 Diabetes (T1D)
- •Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
- •Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
- •Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- •Have an estimated glomerular filtration rate (eGFR) less tham 15 milliliters/minute/1.73 meter squared as determined by the central laboratory
- •Have a prior or planned surgical treatment for obesity
- •Have New York Heart Association Functional Classification IV congestive heart failure
- •Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
- •Have a known clinically significant gastric emptying abnormality
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- •Have any lifetime history of a suicide attempt
- •Had chronic or acute pancreatitis
- •Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
- •Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
时间窗: Baseline, Week 40
次要结局
- 1. Percentage of Participants Who Achieve HbA1c greater than 7.0%(2. Percentage of Participants Who Achieve HbA1c greater than 6.5%)
研究者
Dr Manish Mistry
Eli Lilly and Company (India) Pvt. Ltd.
研究点 (8)
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