NCT05936151已完成2 期
A Phase 2b, Double-Blind Study to Investigate the Effect of Retatrutide on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 42
- 主要终点
- Change from Baseline in Glomerular Filtration Rate (mGFR)
研究概览
简要总结
The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 weeks.
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)
盲法说明
Phase 2b
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 a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)
- •Have either
- •no T2D with an HbA1c < 6.5% or
- •have T2D with an HbA1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening.
- •Have been diagnosed with chronic kidney disease (CKD).
排除标准
- •Have a self-reported change in body weight >5 kilogram (kg) (11 pounds) within 90 days before screening.
- •Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting insulins or U500 Insulin
- •Have a prior or planned surgical treatment for obesity
- •Have Type 1 Diabetes (T1D)
- •Have acute or chronic hepatitis
- •Have a history of malignant disease within 5 years before screening.
研究组 & 干预措施
Retatrutide
Experimental
Participants will receive multiple doses of retatrutide subcutaneously (SC)
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive LY3437943
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Glomerular Filtration Rate (mGFR)
时间窗: Baseline, Week 24
The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)
次要结局
- Change from Baseline in Medulla T1 (ms) (MRI)(Baseline, Week 24)
- Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)(Baseline, Week 24)
- Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)(Baseline, Week 24)
- Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)(Baseline, Week 24)
- Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit(Baseline, Week 24)
- Change from Baseline in in Mean Arterial Flow (MAF)(Baseline, Week 24)
- Change from Baseline in Medulla R2(Baseline, Week 24)
- Change from Baseline in Renal Artery Resistive Index (RARI)(Baseline, Week 24)
- Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)(Baseline, Week 24)
- Change from Baseline in Global Renal Perfusion (MRI)(Baseline, Week 24)
- Change from Baseline in Total Renal Parenchyma Volume (MRI)(Baseline, Week 24)
- Change from Baseline in Renal Cortex Volume (MRI)(Baseline, Week 24)
- Change from Baseline in Renal Cortex T1 (ms) (MRI)(Baseline, Week 24)
- Change from Baseline in Renal Cortex R2 (BOLD MRI)(Baseline, Week 24)
- Change from Baseline in Body Weight(Baseline, Week 24)
- Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)(Baseline, Week 24)
- Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))(Baseline, Week 24)
研究者
研究点 (42)
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