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

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.

NCT Number	NCT07496177
Lead Sponsor	Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences Collaborators: Weifang People's Hospital, Shenzhen HighTide Biopharmaceutical Ltd.
Conditions	T2DM, CKD
Enrollment	75 participants
Start Date	2026-07-09
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-15