CTRI/2024/01/061307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 Type 2 Diabetes and Inadequate Glycemic Control with Diet and Exercise Alone (ACHIEVE-1)
Eli Lilly Company India Pvt Ltd10 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2024年1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
- 520
- 试验地点
- 10
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.
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 Type 2 Diabetes.
- •Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
- •Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
- •Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
- •Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.
排除标准
- •Have Type 1 Diabetes.
- •Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
- •Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- •Have New York Heart Association functional classification IV congestive heart failure.
- •Have acute or chronic hepatitis.
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
- Change from Baseline in Fasting Serum Glucose(Percentage Change from Baseline in Body Weight)
- Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)(Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol))
研究者
研究点 (10)
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