Study Testing HTD1801 Capsules to Slow Kidney Damage in Adults With Type 2 Diabetes and Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating the investigational drug HTD1801 to see if it can slow kidney damage progression in adults who have both Type 2 Diabetes T2DM and Chronic Kidney Disease CKD. The main focus is to determine if HTD1801 can reduce or limit the increase in urine albumin-to-creatinine ratio UACR compared to a placebo. This Phase 2 randomized, double-blind study aims to understand the drugs effect on kidney function decline in this population. Participants will be randomly assigned to take either HTD1801 capsules 1000mg as 4 capsules or matching placebo capsules twice daily for 12 weeks. The study involves weekly clinic visits for the first 4 weeks, followed by visits every 4 weeks, during which various assessments and check-ups are conducted. The study drug or placebo is taken orally, and safety is closely monitored through health reports and routine laboratory tests. During the study, participants will attend scheduled visits for assessments including urine and blood tests to measure kidney function and other health markers. The primary outcome measured is the relative change in UACR from baseline at 12 weeks. Secondary outcomes include changes in estimated glomerular filtration rate eGFR, albumin excretion rate, inflammatory markers, blood sugar levels, and cholesterol. Safety monitoring continues throughout the trial to track any health changes or adverse effects.

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