A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment 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.
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∙ 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.