RecruitingPhase 4

A Research Study Looking at Kidney and Heart Health in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China

A Study of Kidney and Cardiovascular Endpoints in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

300

Study population

Cardiovascular Risk, Chronic kidney disease

Eligibility highlights

Primary endpoint

•First occurrence of a composite endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07900438

Org study IDNN9535-8615

Secondary IDUT111-1328-4876World Health Organization (WHO)

Timeline

Milestones

Study start2026-10-12actual

Study first posted2026-10-28actual

Last update posted2026-10-28actual

Primary completion2029-12-20estimated

Study completion2030-01-24estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Cardiovascular RiskChronic kidney disease

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age 18 years or above at the time of signing the informed consent

2. Diagnosed with type 2 diabetes (T2D)

3. HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole [mmol/mol])

4. Kidney impairment defined either by:

-serum creatinine-based eGFR greater than or equal to (≥) 50 and less than or equal to (≤) 75 mL/min/1.73 m^2 (CKD-EPI, 2009) and UACR greater than (>) 300 and less than (<) 5000 milligrams per gram (mg/g) or

-serum creatinine-based eGFR ≥ 25 and < 50 mL/min/1.73 m^2 (CKD-EPI, 2009) and UACR > 100 and < 5000 mg/g

5. Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of inclusion criterion and kept stable until screening.

Laboratory results for inclusion can be based on:

•measurements no more than 90 days old at screening, documented in medical records or

•central laboratory measurement obtained at the screening visit If using UACR and eGFR values from medical records for inclusion, these values must be entered in the electronic case report form.

The number of participants with inclusion eGFR ≥ 60 mL/min/1.73 m^2 will be capped at 20% of enrolled participants.

Exclusion criteria

1. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.

2. Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA) within 30 days prior to screening. This also includes dual agonists containing a GLP1 RA component.

3. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.

4. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.

5. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and optical coherence tomography performed within the past 90 days prior to screening or in the period between screening and enrolment. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.

6. Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB).

Endpoints (10)

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

Cardiovascular outcomes

Safety / tolerability / PK

Glycemic / diabetes

Other clinical outcomes

Cardiovascular outcomes

2 endpoints

Primary/protocol endpoint

Time to first occurrence of a composite endpoint consisting of: Onset of persistent reduction of ≥ 50% in eGFR compared with baseline, Onset of persistent eGFR < 15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death, CV death