Kidney and Heart Health in Adults with Type 2 Diabetes and CKD Treated with Semaglutide in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study investigates the effects of semaglutide on kidney and cardiovascular outcomes in adults with T2D and CKD in China. Participants will receive semaglutide by injection and will be followed for about 60 to 172 weeks to assess safety and organ health. Eligible adults have type 2 diabetes, CKD within specified eGFR and albuminuria ranges, controlled HbA1c, and stable RAAS blockade if tolerated. The study is sponsored by Novo Nordisk A/S with multiple nephrology-focused sites in Beijing and Fuyang.

Why it matters

Who can join: the full rules

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).

Where it's running

• Beijing Anzhen Hospital, Capital Medical University-Nephrology
  Beijing, Beijing Municipality, China Recruiting
• Fu Yang People's Hospital-Nephrology
  Fuyang, Anhui, China Not yet recruiting
• Peking University First Hospital-Nephrology
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Friendship Hospital, Capital Medical University-Nephrology
  Beijing, Beijing Municipality, China Not yet recruiting
• The Second Hospital & Clinical Medical School, Lanzhou University-Nephrology
  Lanzhou, Gansu, China Not yet recruiting
• Huizhou Central People's Hospital-Endocrinology
  Huizhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.