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2024年6月21日

干预措施Placebo HRS-7535

概览

阶段: 2 期
干预措施: Placebo
疾病 / 适应症: 未指定
发起方: Shandong Suncadia Medicine Co., Ltd.
入组人数: 281
试验地点: 1
主要终点: Ratio of UACR at week 16 to UACR at baseline
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2024年6月21日

结束日期

2025年7月25日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Shandong Suncadia Medicine Co., Ltd.

责任方

Sponsor

入排标准

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

干预措施: Placebo

Group B，Subjects will receive HRS-7535 administered orally

干预措施: HRS-7535

Group C，Subjects will receive escalated HRS-7535 administered orally

干预措施: HRS-7535

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)