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A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.

NCT07496177 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-27

No results posted yet for this study

Summary

Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).

Main Question it Aims to Answer:

▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?

Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.

Participants will:

* Undergo screening tests to determine eligibility.
* Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.
* Take the study medication twice daily for 12 weeks.
* Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.
* Have their safety monitored through reporting of any health changes and routine lab tests.

Conditions

Interventions

DRUG

HTD1801

1000mg (as 4 capsules), twice a day for 12 weeks

OTHER

placebo

4 placebo capsules, twice a day for 12 weeks.

Sponsors & Collaborators

  • Weifang People's Hospital

    collaborator OTHER

  • Shenzhen HighTide Biopharmaceutical Ltd.

    collaborator UNKNOWN

  • Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jiandong Jiang · Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

  • Lulu Wang · Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496177 on ClinicalTrials.gov