NCT06037252进行中（未招募）2 期
A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 414
- 试验地点
- 40
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
详细描述
The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
- •Have had stable body weight (±5%) during the 90 days preceding screening.
- •Have been diagnosed with Type 2 Diabetes (T2D).
- •Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.
排除标准
- •Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- •Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
- •Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- •Have a prior or planned surgical treatment for obesity.
- •Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
- •Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².
- •Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
- •acute myocardial infarction.
- •cerebrovascular accident (stroke).
- •unstable angina .
- •hospitalization due to congestive heart failure, or
- •coronary artery revascularization.
- •Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type
- •Have a history of chronic or acute pancreatitis.
研究组 & 干预措施
Tirzepatide High Dose 1
Experimental
Participants will receive tirzepatide subcutaneously (SC).
干预措施: Tirzepatide (Drug)
Tirzepatide High Dose 2
Experimental
Participants will receive tirzepatide SC.
干预措施: Tirzepatide (Drug)
Tirzepatide
Active Comparator
Participants will receive tirzepatide SC.
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline (Week 0), Week 44
次要结局
- Absolute Change from Baseline in Body Weight(Baseline (Week 24), Week 80)
- Change from Baseline in Body Mass Index (BMI)(Baseline (Week 0), Week 44)
- Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline (Week 0), Week 80)
- Change from Baseline in HbA1c(Baseline (Week 24), Week 80)
- Percent Change from Baseline in Body Weight(Baseline (Week 24), Week 80)
- Change from Baseline in BMI(Baseline (Week 24), Week 80)
- Change from Baseline in Waist Circumference(Baseline (Week 24), Week 80)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 44)
- Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline (Week 0), Week 44)
- Change from Baseline in HbA1c(Baseline (Week 0), Week 44)
- Absolute Change from Baseline in Body Weight(Baseline (Week 0), Week 44)
- Change from Baseline in Waist Circumference(Baseline (Week 0), Week 44)
研究者
研究点 (40)
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