Current partner codePEPTIDESDE
NCT07537088·Phase 4·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

468

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

Dulaglutide

Dulaglutide 1.5 mg, once weekly

DRUG

SGLT2i

administered according to prescribing information

DRUG

Finerenone

administered according to prescribing information

Timeline

From registration to results.

  1. First posted

    Apr 17, 2026

  2. Study start

    May 2026

  3. Primary completion

    Apr 2027

  4. Study completion

    Jul 2027

  5. Results posted

    Not reported

  6. Registry updated

    Apr 22, 2026

Outcomes

What the study measures.

Primary outcomes

Urine Albumin-to-Creatinine Ratio(UACR)

Time frame · Change in UACR from baseline at Week 26

Secondary outcomes

estimated Glomerular Filtration Rate(eGFR)

Time frame · Change from baseline at Week 13 and Week 26

Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula

eGFR slope

Time frame · Change from baseline at Week 13 and Week 26

the change in eGFR per unit of time

Hemoglobin A1c(HbA1c)

Time frame · Change from baseline at Week 13 and Week 26

weight

Time frame · Change from baseline at Week 13 and Week 26

lipid profile

Time frame · Change from baseline at Week 13 and Week 26

Total Cholesterol(TC), Triglyceride(TG), Low-Density Lipoprotein Cholesterol(LDL-C), High-Density Lipoprotein Cholesterol(HDL-C)

serum creatinine

Time frame · Change from baseline at Week 13 and Week 26

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) * 2.Hemoglobin A1c (HbA1c) 7.0%-11% * 3.Urine albumin-to-creatinine ratio (UACR) 300-5000 mg/g * 4.Body mass index (BMI) 21-45 kg/m² * 5.Having received combination therapy with SGLT2 inhibitor and finerenone for 3 months or longer, on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi) * 6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol Exclusion Criteria: * 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 * 4.History of diabetic ketoacidosis (DKA) within the past 6 months * 5.Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² * 6.Hospitalization within 30 days prior to screening for acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery * 7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening * 8.Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at screening, or patients judged by the investigator to have hypovolemia * 9.Serum potassium \>5.0 mmol/L at screening * 10.Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone) * 11.Patients receiving or with clear clinical indications requiring systemic immunosuppressive therapy (including but not limited to prednisone, cyclosporine, etc.) for other kidney diseases (e.g., primary or secondary glomerulonephritis, lupus nephritis) * 12.History of recurrent urinary tract or genital infections (as judged by the investigator) * 13.Life expectancy \<1 year at screening * 14.Confirmed malignancy * 15.Participation in another clinical trial within 3 months prior to screening * 16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.