DelfaGLP-1 Atlas

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Not yet recruitingPhase 4

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

Efficacy and Safety of Dulaglutide, SGLT-2 Inhibitors, and Finerenone Triple Therapy in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease: A Multicenter, Prospective, Randomized Controlled Study

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

468

estimated

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•BMI 21-45•HbA1c 7-11%•UACR 300-5000

Primary endpoint

•UACR, change

Identifiers

Registered as

NCT IDNCT07537088
Org study ID2026-ethics-58

Timeline

Milestones

Study first posted2026-04-17actual
Last update posted2026-04-22actual
Study start2026-05estimated (month precision)
Primary completion2027-04estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney
5
Cardiovascular outcomes
1
Weight & body composition
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

1 endpoint
Other/protocol endpoint

composite cardiovascular outcome

Time frame:From enrollment to the end of treatment at week 26

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Weight & body composition

1 endpoint
Secondary/protocol endpoint

weight

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

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Hemoglobin A1c(HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

5 endpoints
Primary/protocol endpoint

Urine Albumin-to-Creatinine Ratio（UACR）

Time frame:Change in UACR from baseline at Week 26

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

estimated Glomerular Filtration Rate(eGFR)

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

eGFR slope

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

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

serum creatinine

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

change from baseline, improvement

Other/protocol endpoint

composite kidney outcome

Time frame:From enrollment to the end of treatment at week 26

Custom renal composite

time to event, event

componentseGFR, change, End-stage renal disease, Kidney-replacement therapy, Renal death

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

lipid profile

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.