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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: T2DM, CKD

In brief

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.

Key facts

Study ID

NCT07496177

Run by

Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences

People needed

75

Starts

2026-07-09

Expected to finish

2027-06-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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…

• Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.
• 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.
• Planned coronary, carotid, or peripheral arterial revascularization.
• Uncontrolled hypertension despite antihypertensive therapy, defined as sustained SBP >150 mmHg and/or DBP >100 mmHg.
• Hematologic Disease:
• Hematologic disorders or any condition causing hemolysis or red blood cell instability at screening, including but not limited to: glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, hemolytic anemia, iron deficiency anemia, aplastic anemia, chronic malaria, splenectomy, reticulocytopenia.
• Oncology:
• History of or current malignancy within the past 2 years, except for basal cell carcinoma or excised non-invasive squamous cell carcinoma of the skin.
• Current, planned, or anticipated treatment with radiotherapy, cytotoxic chemotherapy, or immunomodulators (e.g., interleukins, interferons). Long-term stable use of immunosuppressants is permitted if approved by the investigator.
• Diagnostic Assessments:
• Clinically significant laboratory abnormalities or ECG changes at screening, including but not limited to:

Where it is running

• Weifang People's Hospital — Weifang, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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