NCT06415214

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 21, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

January 5, 2026

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

May 10, 2024

Last Update Submit

December 31, 2025

Conditions

Diabetic Kidney Disease, Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Ratio of UACR at week 16 to UACR at baseline

    at Week 16

Secondary Outcomes (11)

  • 24 hour urine analysis results at Week 16

    at Week 16

  • Proportion of subjects with a 30% decrease in UACR from baseline at Week 16

    at Week 16

  • Change from baseline in eGFR at Week 16

    at Week 16

  • Change from baseline in HbA1c at Week 16

    at Week 16

  • Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16

    at Week 16

  • +6 more secondary outcomes

Study Arms (3)

Group A，Subjects will receive Placebo administered orally

PLACEBO COMPARATOR
Drug: Placebo

Group B，Subjects will receive HRS-7535 administered orally

EXPERIMENTAL
Drug: HRS-7535

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

EXPERIMENTAL
Drug: HRS-7535

Interventions

HRS-7535DRUG

HRS-7535

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

Placebo

Group A，Subjects will receive Placebo administered orally

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

June 21, 2024

Primary Completion

July 15, 2025

Study Completion

July 25, 2025

Last Updated

January 5, 2026

Record last verified: 2025-05

Locations

CN(1)