NCT06354660已完成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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 48
- 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
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 Diabetes (T2D)
- •Have HbA1c ≥ 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) ≥ 23.0 kilograms per meter squared (kg/m^2)
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) <15 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) 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.
研究组 & 干预措施
Retatrutide Dose Level 1
Experimental
Participants will receive retatrutide administered subcutaneously (SC).
干预措施: Retatrutide (Drug)
Retatrutide Dose Level 2
Experimental
Participants will receive retatrutide administered SC.
干预措施: Retatrutide (Drug)
Retatrutide Dose Level 3
Experimental
Participants will receive retatrutide administered SC.
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo administered SC.
干预措施: Placebo (Drug)
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
- Percent Change from Baseline in Body Weight(Baseline, Week 40)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 40)
- Change from Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants Who Achieve HbA1c < 7.0%(Week 40)
- Percentage of Participants Who Achieve HbA1c ≤ 6.5%(Week 40)
- Percentage of Participants Who Achieve HbA1c < 5.7%(Week 40)
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol(Baseline, Week 40)
- Percentage of Participants Who Achieve Weight Reduction of ≥ 5%(Week 40)
- Percentage of Participants Who Achieve Weight Reduction of ≥ 10%(Week 40)
- Percentage of Participants Who Achieve Weight Reduction of ≥ 15%(Week 40)
- Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction(Week 40)
- Percent Change from Baseline in Triglycerides(Baseline, Week 40)
研究者
研究点 (48)
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