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

Plain-language guide to NCT07537088: phase 4 randomized trial of Dulaglutide, 468 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07537088
Phase
phase 4
Status
not yet recruiting
Start
2026-05
Completion (planned or actual)
2027-04
Participants
468 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
T2DM (Type 2 Diabetes Mellitus); CKD - Chronic Kidney Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Dulaglutide.

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).

It had two arms (groups): SGLT2i + Finerenone + Dulaglutide group (experimental) and SGLT2i + Finerenone group (active comparator).

The registry classes the interventions as drug.

Who Took Part

468 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). 4.Body mass index (BMI) 21-45 kg/m². 6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: 1.pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception; 2.history of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (glp-1ra), sglt2 inhibitors, or finerenone; 3.type 1 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-05 with completion listed for 2027-04.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Urine Albumin-to-Creatinine Ratio(UACR) (time frame: Change in UACR from baseline at Week 26).

It also tracked 6 secondary outcomes, for example estimated Glomerular Filtration Rate(eGFR), eGFR slope, Hemoglobin A1c(HbA1c), weight, lipid profile and serum creatinine.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 468 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.

Our Notes on the Compound

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.