NCT06415214已完成2 期
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Diabetic Kidney Disease in Type 2 Diabetes
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2024年6月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Ratio of UACR at week 16 to UACR at baseline
研究概览
简要总结
The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with diabetic kidney disease in type 2 diabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects, 18-75 years of age at the time of signing informed consent;
- •Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
- •Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
- •Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
- •UACR ≥300 and <3000 mg/g;
- •HbA1c ≥6.5% and ≤10.0%;
- •ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks;
- •Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);
- •Able and willing to provide a written informed consent;
排除标准
- •Have type 1 diabetes mellitus or specific type of diabetes;
- •Acute kidney injury or dialysis treatment within 6 months;
- •Kidney transplantation is planned during the trial;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
- •history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
研究组 & 干预措施
Group A，Subjects will receive Placebo administered orally
Placebo Comparator
干预措施: Placebo (Drug)
Group B，Subjects will receive HRS-7535 administered orally
Experimental
干预措施: HRS-7535 (Drug)
Group C，Subjects will receive escalated HRS-7535 administered orally
Experimental
干预措施: HRS-7535 (Drug)
结局指标
主要结局
Ratio of UACR at week 16 to UACR at baseline
时间窗: at Week 16
次要结局
- Proportion of subjects with a 30% decrease in UACR from baseline at Week 16(at Week 16)
- Change from baseline in insulin at Week 16(at Week 16)
- Proportion of subjects receiving glycemic rescue medicine at Week 16(at Week 16)
- Change from baseline in FPG at Week 16(at Week 16)
- Change from baseline in HbA1c at Week 16(at Week 16)
- 24 hour urine analysis results at Week 16(at Week 16)
- Change from baseline in eGFR at Week 16(at Week 16)
- Change from baseline in c-peptide at Week 16(at Week 16)
- Change from baseline in body weight at Week 16(at Week 16)
- Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16(at Week 16)
- A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16(at Week 16)
研究者
研究点 (1)
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