Phase 4 Dulaglutide Triple Therapy for T2DM Chronic Kidney Disease
ClinicalTrials.gov Studies
Summary
A Phase 4 clinical trial (NCT07537088) has been registered on ClinicalTrials.gov evaluating dulaglutide as add-on therapy for Chinese adults with Type 2 Diabetes and Chronic Kidney Disease. The 26-week randomized study will assess whether adding dulaglutide to existing SGLT2 inhibitor plus finerenone therapy provides additional kidney protection. Participants must have been on stable combination therapy for at least 3 months before enrollment.
What changed
A new clinical trial registration has been posted for a Phase 4 study evaluating the efficacy and safety of adding dulaglutide to combination therapy with SGLT2 inhibitors and finerenone in Chinese adults with Type 2 Diabetes and Chronic Kidney Disease. The randomized controlled study will enroll adults with T2DM and mild-to-moderate CKD who have been on stable SGLT2i plus finerenone therapy for at least 3 months, with the primary endpoint assessing kidney protection at 26 weeks.
For pharmaceutical manufacturers and clinical investigators, this trial registration represents standard regulatory compliance activity on ClinicalTrials.gov. Trial sponsors conducting interventional studies must register within 21 days of enrollment of the first participant under FDA requirements. Healthcare providers treating T2DM patients with CKD may consider this study relevant for understanding emerging triple therapy approaches. The study population is specifically Chinese adults, limiting generalizability to other populations.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
Phase 4 NCT07537088 Kind: PHASE4 Apr 17, 2026
Abstract
The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of SGLT2i and finerenone can provide additional kidney protection and safety for Chinese adults with T2DM and 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).
Conditions: T2DM, CKD - Chronic Kidney Disease
Interventions: Dulaglutide, SGLT2i, Finerenone
Named provisions
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.