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

NCT07496177 | Not Yet Recruiting Phase 2

• 2 other identifiers: IMB-CT-2026-001WFPH-2026-IIT-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

T2DM; CKD

Outcome Measures

Primary Outcomes (1)

• Relative change in urine albumin-to-creatinine ratio (UACR) from baseline

  Relative change in urine albumin-to-creatinine ratio (UACR) from baseline at Week 12

  12 weeks

Secondary Outcomes (13)

• Proportion of subjects achieving a ≥30% reduction in UACR and a <30% decline in eGFR

  12 weeks

• Change in albumin excretion rate from baseline.

  12 weeks

• The percentage of patients who achieved at least a 30% and at least a 50% reduction in UACR.

  12 weeks

• Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline

  12 weeks

• Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline.

  12 weeks

Study Arms (2)

HTD1801

EXPERIMENTAL

Patients take HTD1801 capsules, 1000mg (as 4 capsules), twice a day for 12 weeks.

Drug: HTD1801

placebo

PLACEBO COMPARATOR

Patients take 4 placebo capsules, twice a day for 12 weeks.

Other: placebo

Interventions

HTD1801 DRUG

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

HTD1801

placebo OTHER

4 placebo capsules, twice a day for 12 weeks.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for the study:
• Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
• Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:
• A urine albumin-to-creatinine ratio (UACR) \>200 mg/g on at least two separate occasions before screening.
• A clinical diagnosis of CKD (KDIGO stage G1 to G3b) for at least 3 months, and an estimated glomerular filtration rate (eGFR) between 30 and 120 ml/min/1.73 m² at screening (using the CKD-EPI creatinine-cystatin C formula).
• Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.
• At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks.
• Body Mass Index (BMI) at screening between 18.5 kg/m² and 40 kg/m². Weight must be stable (no loss \>10% in the 3 months before baseline) with no major lifestyle changes in the 3 months before screening.
• For women of childbearing potential and sexually active men with partners of childbearing potential: agreement to use highly effective contraception or practice abstinence throughout the study and for 30 days after the last dose.
• Able to understand, sign the informed consent form, and comply with the study protocol.

You may not qualify if:

• Kidney Disease:
• Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.
• Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.
• Liver Disease:
• Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).
• History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).
• Presence of the following acute or chronic liver diseases at screening: autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson's disease, or drug-induced liver injury.
• Gastrointestinal Disease:
• History of gastric bypass surgery.
• History of peptic or gastrointestinal ulcer within 12 months prior to randomization.
• History of clinically active inflammatory bowel disease within 12 months prior to randomization.
• Severe gastrointestinal disease at screening that affects drug absorption, distribution, metabolism, or excretion, including chronic conditions causing recurrent diarrhea (e.g., irritable bowel syndrome, ulcerative colitis, Crohn's disease).
• Cardiovascular Disease:
• History of myocardial infarction, stroke, uncontrolled arrhythmia, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening.
• Current or previous history of New York Heart Association (NYHA) Class IV congestive heart failure.

Sponsors & Collaborators

• Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences: lead
• Weifang People's Hospital: collaborator
• Shenzhen HighTide Biopharmaceutical Ltd.: collaborator

Study Sites (1)

Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

Study Officials

• Jiandong Jiang

  Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

• Lulu Wang

  Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Shen

CONTACT

86-10-63170236; j2025080011@pumc.edu.cn

Xingpeng Shi

CONTACT

86-536-8192261; shixingpeng11@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)