Study of Oral NLRP3 Inhibitor Dapansutrile for Treatment of Type 2 Diabetes and Related Complications Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

What this Trial Is About

Researchers are evaluating dapansutrile, an oral NLRP3 inhibitor, as a potential new treatment option for managing type 2 diabetes and its related complications. This study focuses on whether dapansutrile, which has shown promising preclinical and safety results, can reduce inflammation and address risks for cardiovascular disease associated with diabetes. The trial is a phase 2, randomized, double-blind, placebo-controlled study over 26 weeks. Participants will be randomly assigned to receive either 1000 mg of dapansutrile twice daily or a matching placebo for 26 weeks. All tablets are self-administered orally with or without food. The study compares the effects of dapansutrile against placebo on blood sugar control and inflammation over the treatment period. Throughout the trial, participants will undergo regular blood tests to measure HbA1c and fasting plasma glucose levels at baseline and multiple time points up to week 26. Researchers will also assess markers of inflammation and monitor safety. The primary outcome is the change in HbA1c from baseline to week 26. Participants are expected to complete all study procedures over approximately six months, with ongoing safety and efficacy evaluations.

Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia