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Cardiovascular RiskPhase 4NCT07900438

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 study testing Semaglutide in people with Cardiovascular Risk and Chronic Kidney Disease, run by Novo Nordisk A/S at 26 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Risk, Chronic Kidney Disease
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
26 sitesChina
Study dates
12 Oct 2026to 24 Jan 2030
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

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
  • 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.
  • Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.
  • 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).

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

26 sites in 1 country

China26 sites, 26 recruiting

  • The People's Hospital of Anyang City/ TGE Center Hospital of Anyang City-Nephrology

    Anyang, Henan, 455099

    Not yet recruiting

  • The First Affiliated Hospital of Baotou Medical College-Nephrology

    Baotou, Inner Mongolia, 014017

    Not yet recruiting

  • Beijing Anzhen Hospital, Capital Medical University-Nephrology

    Beijing, Beijing Municipality, 100029

    Recruiting

  • Peking University First Hospital-Nephrology

    Beijing, Beijing Municipality, 100034

    Not yet recruiting

  • Beijing Friendship Hospital, Capital Medical University-Nephrology

    Beijing, Beijing Municipality, 100050

    Not yet recruiting

  • The Second Norman Bethune Hospital of Jilin University-Nephrology

    Changchun, Jilin, 130033

    Not yet recruiting

  • Changzhou No.2 People's Hospital-Nephrology

    Changzhou, Jiangsu, 213003

    Not yet recruiting

  • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Nephrology

    Chengdu, Sichuan, 610071

    Not yet recruiting

  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital) -Nephrology

    Dalian, Liaoning, 116033

    Not yet recruiting

  • Fu Yang People's Hospital-Nephrology

    Fuyang, Anhui, 236000

    Not yet recruiting

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong, 516001

    Not yet recruiting

  • Jinan Central Hospital-General Medicine

    Jinan, Shandong, 250013

    Not yet recruiting

  • The Second Hospital & Clinical Medical School, Lanzhou University-Nephrology

    Lanzhou, Gansu, 730030

    Not yet recruiting

  • Taizhou Hospital of Zhejiang Province-Nephrology

    Linhai, Zhejiang, 317013

    Not yet recruiting

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011

    Not yet recruiting

  • Ningbo No. 2 Hospital-Nephrology

    Ningbo, Zhejiang, 315099

    Not yet recruiting

  • Panjin Liaoyou Gemflower Hospital-Nephrology

    Panjin, Liaoning, 124120

    Not yet recruiting

  • Pingxiang People's Hospital-Endocrinology

    Pingxiang, Jiangxi, 337055

    Not yet recruiting

  • Shanghai General Hospital-Nephrology

    Shanghai, Shanghai Municipality, 200080

    Not yet recruiting

  • The Second Affiliated Hospital of Shantou University Medical College-Nephrology

    Shantou, Guangdong, 515065

    Not yet recruiting

  • The Second Hospital of Hebei Medical University-Nephrology

    Shijiazhuang, Hebei, 050005

    Not yet recruiting

  • Siping City Central People's Hospital-Nephrology

    Siping, Jilin, 136000

    Not yet recruiting

  • Qinghai Provincial People's Hospital-Endocrinology

    Xining, Qinghai, 810007

    Not yet recruiting

  • The Second People's Hospital of Yibin-Department of Nephrology

    Yibin, Sichuan, 644099

    Not yet recruiting

  • Yichang Central People's Hospital-Nephrology

    Yichang, Hubei, 4443003

    Not yet recruiting

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Semaglutide
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • SemaglutideDrug

    Semaglutide is administered subcutaneously once weekly.

Study groups in NCT07900438
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants will receive subcutaneous injection of semaglutide once weekly.
Receives: Drug: Semaglutide

What is being measured

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

  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)

    Measured: From Baseline (Week 0) up to Week 169

Secondary outcomes (9)

  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)

    Measured: From Baseline (Week 0) up to Week 169

  2. Change in eGFR (creatinine CKDEPI, 2012)

    Measured in mL/min/1.73 m^2

    Measured: 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

    Measured: From Baseline (Week 0) up to Week 169

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

    Measured in Percentage (%)

    Measured: From Baseline (Week 0) up to Week 169

  5. Time to all-cause death

    Measured in month(s)

    Measured: 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)

    Measured: From Baseline (Week 0) up to Week 169

  7. Change in glycated haemoglobin (HbA1c)

    Measured in percentage point

    Measured: From Baseline (Week 0) up to Week 169

  8. Number of serious adverse events

    Measured as events

    Measured: From Baseline (Week 0) up to Week 169

  9. Number of severe hypoglycaemic episodes

    Measured as events

    Measured: From Baseline (Week 0) up to Week 169

Timeline

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

  1. First posted28 Oct 2026
  2. Study start12 Oct 2026
  3. Primary completion20 Dec 2029 (estimated)
  4. Study completion24 Jan 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07900438
Sponsor's protocol ID
NN9535-8615
Other IDs
UT111-1328-4876
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide in people with Cardiovascular Risk and Chronic Kidney Disease, run by Novo Nordisk A/S at 26 sites in China.

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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From Baseline (Week 0) up to Week 169). 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 NCT07900438.

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 28 Oct 2026.

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