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RecruitingNCT07900438Updated Oct 28, 2026

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 Phase 4 interventional study of Semaglutide in Cardiovascular Risk and Chronic Kidney Disease, sponsored by Novo Nordisk A/S. Recruiting at 26 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cardiovascular Risk
  • Chronic Kidney Disease
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 300 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or above at the time of signing the
  2. Diagnosed with type 2 diabetes (T2D)
  3. less than or equal to (≤) 10 % (≤ 86 millimoles per mole [mmol/mol])
  4. Kidney impairment defined either by:

    • serum creatinine-based 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 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

Exclusion Criteria:

  1. Congenital or hereditary kidney diseases including polycystic kidney disease, 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 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).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Semaglutide

    Participants will receive subcutaneous injection of semaglutide once weekly.

    Drug: Semaglutide

Interventions

  • Semaglutide is administered subcutaneously once weekly.

06

What researchers measure

Primary outcomes

  1. 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

    Measured in month(s)

    Time frame: From Baseline (Week 0) up to Week 169

Secondary outcomes

  1. Change in estimated glomerular filtration rate (eGFR) (creatinine CKDEPI, 2009)

    Measured in milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2)

    Time frame: From Baseline (Week 0) up to Week 169

  2. Change in eGFR (creatinine CKDEPI, 2012)

    Measured in mL/min/1.73 m\^2

    Time frame: From Baseline (Week 0) up to Week 169

  3. Change in eGFR (cystatin C-creatinine CKD-EPI, 2021)

    Measured in mL/min/1.73 m\^2

    Time frame: From Baseline (Week 0) up to Week 169

  4. Relative change in Urine Albumin-to-Creatinine Ratio (UACR)

    Measured in Percentage (%)

    Time frame: From Baseline (Week 0) up to Week 169

  5. Time to all-cause death

    Measured in month(s)

    Time frame: From Baseline (Week 0) up to Week 169

  6. Time to first occurrence of composite MACE endpoint consisting of Non-fatal myocardial infarction, Non-fatal stroke & CV death

    Measured in month(s)

    Time frame: From Baseline (Week 0) up to Week 169

  7. Change in glycated haemoglobin (HbA1c)

    Measured in percentage point

    Time frame: From Baseline (Week 0) up to Week 169

  8. Number of serious adverse events

    Measured as events

    Time frame: From Baseline (Week 0) up to Week 169

  9. Number of severe hypoglycaemic episodes

    Measured as events

    Time frame: From Baseline (Week 0) up to Week 169

07

Study locations

1 of 26 sites recruiting
  • Fu Yang People's Hospital-Nephrology
    Fuyang, Anhui 236000, China
    Not yet recruiting
  • Beijing Anzhen Hospital, Capital Medical University-Nephrology
    Beijing, Beijing Municipality 100029, China
    Recruiting
  • Peking University First Hospital-Nephrology
    Beijing, Beijing Municipality 100034, China
    Not yet recruiting
  • Beijing Friendship Hospital, Capital Medical University-Nephrology
    Beijing, Beijing Municipality 100050, China
    Not yet recruiting
  • The Second Hospital & Clinical Medical School, Lanzhou University-Nephrology
    Lanzhou, Gansu 730030, China
    Not yet recruiting
  • Huizhou Central People's Hospital-Endocrinology
    Huizhou, Guangdong 516001, China
    Not yet recruiting
  • The Second Affiliated Hospital of Shantou University Medical College-Nephrology
    Shantou, Guangdong 515065, China
    Not yet recruiting
  • The Second Hospital of Hebei Medical University-Nephrology
    Shijiazhuang, Hebei 050005, China
    Not yet recruiting
  • The People's Hospital of Anyang City/ TGE Center Hospital of Anyang City-Nephrology
    Anyang, Henan 455099, China
    Not yet recruiting
  • Yichang Central People's Hospital-Nephrology
    Yichang, Hubei 4443003, China
    Not yet recruiting
  • The First Affiliated Hospital of Baotou Medical College-Nephrology
    Baotou, Inner Mongolia 014017, China
    Not yet recruiting
  • Changzhou No.2 People's Hospital-Nephrology
    Changzhou, Jiangsu 213003, China
    Not yet recruiting
  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
    Nanjing, Jiangsu 210011, China
    Not yet recruiting
  • The Affiliated Hospital of Jiangsu University-Endocrinology
    Zhenjiang, Jiangsu 212001, China
    Not yet recruiting
  • Pingxiang People's Hospital-Endocrinology
    Pingxiang, Jiangxi 337055, China
    Not yet recruiting
  • The Second Norman Bethune Hospital of Jilin University-Nephrology
    Changchun, Jilin 130033, China
    Not yet recruiting
  • Siping City Central People's Hospital-Nephrology
    Siping, Jilin 136000, China
    Not yet recruiting
  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital) -Nephrology
    Dalian, Liaoning 116033, China
    Not yet recruiting
  • Panjin Liaoyou Gemflower Hospital-Nephrology
    Panjin, Liaoning 124120, China
    Not yet recruiting
  • Qinghai Provincial People's Hospital-Endocrinology
    Xining, Qinghai 810007, China
    Not yet recruiting
  • Jinan Central Hospital-General Medicine
    Jinan, Shandong 250013, China
    Not yet recruiting
  • Shanghai General Hospital-Nephrology
    Shanghai, Shanghai Municipality 200080, China
    Not yet recruiting
  • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Nephrology
    Chengdu, Sichuan 610071, China
    Not yet recruiting
  • The Second People's Hospital of Yibin-Department of Nephrology
    Yibin, Sichuan 644099, China
    Not yet recruiting
  • Taizhou Hospital of Zhejiang Province-Nephrology
    Linhai, Zhejiang 317013, China
    Not yet recruiting
  • Ningbo No. 2 Hospital-Nephrology
    Ningbo, Zhejiang 315099, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900438
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Oct 12, 2026
Primary completion
Dec 20, 2029 (estimated)
Completion
Jan 24, 2030 (estimated)
Last update
Oct 28, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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