drugset / Trial / NCT07537088

Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease

NCT07537088

Phase 4 Not yet recruiting 468 enrolled First Affiliated Hospital of Wannan Medical College
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).

Timeline

Start
2026-05
Primary completion
2027-04
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide 1.5 mg
Background Finerenone Small molecule