New triple therapy aims to protect kidneys in diabetes patients
NCT ID NCT07537088
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a weekly injection called dulaglutide to two standard pills (SGLT-2 inhibitors and finerenone) can better protect the kidneys of Chinese adults with type 2 diabetes and mild-to-moderate chronic kidney disease. About 468 participants will be randomly assigned to either continue their current two-drug regimen or add dulaglutide for 26 weeks. The main goal is to see if the triple therapy reduces protein in the urine, a key sign of kidney damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dulaglutide (a once-weekly injection for diabetes) added to SGLT-2 inhibitors and finerenone (both pills)
- What this could lead to
- If it works, this could point toward a better way to slow kidney damage in people with type 2 diabetes and chronic kidney disease.
- What could go wrong
- This is a phase 4 trial with 468 participants over 26 weeks, so results may not apply to all patients. Adding dulaglutide may increase side effects like nausea or diarrhea without clear kidney benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 468 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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