NCT06297603进行中（未招募）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, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 148
- 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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 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% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
- •Have moderate or severe renal impairment
- •Have been on the following stable diabetes treatment during 90 days prior to screening
- •basal insulin (≥20 International Units (IU)/day) with or without
- •metformin and/or SGLT2 inhibitor
- •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/m2)
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 a history of unstable or rapidly progressing renal disease
- •Have a prior or planned surgical treatment for obesity
- •Have New York Heart Association Functional Classification III or IV congestive heart failure
- •Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type
- •Have any lifetime history of a suicide attempt
- •Had chronic or acute pancreatitis
- •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 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)
Retatrutide Dose 1
Experimental
Participants will receive retatrutide administered subcutaneously (SC).
干预措施: Retatrutide (Drug)
Retatrutide Dose 2
Experimental
Participants will receive retatrutide administered SC.
干预措施: Retatrutide (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
时间窗: Baseline, Week 52
次要结局
- Percentage of Participants Achieving HbA1c <7.0%(Week 52)
- Percentage of Participants Achieving HbA1c ≤6.5%(Week 52)
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 52)
- Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL(Week 52)
- Percent Change from Baseline in Body Weight(Baseline, Week 52)
- Change from Baseline in Body Weight(Baseline, Week 52)
- Percentage of Participants Achieving Weight Reduction of ≥5%(Week 52)
- Percentage of Participants Achieving Weight Reduction of ≥10%(Week 52)
- Percentage of Participants Achieving Weight Reduction of ≥15%(Week 52)
- Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction(Week 52)
- Percent Change from Baseline in Non-HDL Cholesterol(Baseline, Week 52)
- Percent Change from Baseline in Triglycerides(Baseline, Week 52)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 52)
研究者
研究点 (148)
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