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T2DM (Type 2 Diabetes Mellitus)Phase 4NCT07537088

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

A Phase 4 study testing Dulaglutide, SGLT2i and Finerenone in people with T2DM (Type 2 Diabetes Mellitus) and CKD - Chronic Kidney Disease, run by First Affiliated Hospital of Wannan Medical College.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dulaglutide, SGLT2i and Finerenone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
468 participants
Where
No sites listed yet
Study dates
May 2026to Jul 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jialin Gao contact

0553-5739315

gaojialin-ktz@wnmc.edu.cn

About this study

Official title: 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

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).

Being tested
Dulaglutide, SGLT2i, Finerenone
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Dulaglutide 1.5 mg, once weekly

  • SGLT2iDrug

    administered according to prescribing information

  • FinerenoneDrug

    administered according to prescribing information

Study groups in NCT07537088
Study groupRoleWhat they receive
SGLT2i + Finerenone + Dulaglutide groupExperimentalParticipants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy
Receives: Drug: Dulaglutide; Drug: SGLT2i; Drug: Finerenone
SGLT2i + Finerenone groupActive comparatorParticipants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide
Receives: Drug: SGLT2i; Drug: Finerenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine Albumin-to-Creatinine Ratio（UACR）

    Measured: Change in UACR from baseline at Week 26

Secondary outcomes (6)

  1. estimated Glomerular Filtration Rate(eGFR)

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

    Measured: Change from baseline at Week 13 and Week 26

  2. eGFR slope

    the change in eGFR per unit of time

    Measured: Change from baseline at Week 13 and Week 26

  3. Hemoglobin A1c(HbA1c)

    Measured: Change from baseline at Week 13 and Week 26

  4. weight

    Measured: Change from baseline at Week 13 and Week 26

  5. lipid profile

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

    Measured: Change from baseline at Week 13 and Week 26

  6. serum creatinine

    Measured: Change from baseline at Week 13 and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
468 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537088
Sponsor's protocol ID
2026-ethics-58
Status last verified
Apr 2026
First submitted
12 Apr 2026
Last updated
22 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dulaglutide, SGLT2i and Finerenone in people with T2DM (Type 2 Diabetes Mellitus) and CKD - Chronic Kidney Disease, run by First Affiliated Hospital of Wannan Medical College.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jialin Gao (0553-5739315, gaojialin-ktz@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine Albumin-to-Creatinine Ratio（UACR） (time frame: Change in UACR from baseline at Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07537088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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