Kidney and heart health with semaglutide in adults with diabetes and kidney disease

Trial details

Who runs it

Novo Nordisk A/S

Trial code

NCT07900438

Record updated

28 October 2026

Original description

The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin. The clinical study will also look at whether this medicine is safe for adults who have type 2 diabetes (T2D) and chronic kidney disease (CKD). This study will last for about 60 to 172 weeks.Read full original descriptionShow less

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

The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin. The clinical study will also look at whether this medicine is safe for adults who have type 2 diabetes (T2D) and chronic kidney disease (CKD). This study will last for about 60 to 172 weeks.

Inclusion: Age 18 years or above at the time of signing the informed consent; Diagnosed with type 2 diabetes (T2D); HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole [mmol/mol]); 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; 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: 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; Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening; 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; Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB); Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations; Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.

ClinicalTrials.gov NCT07900438