Not yet recruitingPhase NA

Study on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-Diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria

Study on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria

Lead sponsor

Peking University People's Hospital

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

266

Study population

Chronic kidney disease, Obesity / overweight

Eligibility highlights

•BMI ≥28•eGFR ≥25•UACR 100-3500

Primary endpoint

•Urinary Albumin-to-Creatinine Ratio (UACR)

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 IDNCT07849348

Org study ID2026PHD018-001

Timeline

Milestones

Study first posted2026-09-30actual

Last update posted2026-09-30actual

Study start2026-09estimated (month precision)

Primary completion2027-02estimated (month precision)

Study completion2027-02estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1. Age >=18 years at the time of signing the informed consent form, without gender restriction;

•2. Meet one of the following definitions of excess adiposity at screening:

1. BMI >=28 kg/m^2 and waist-to-height ratio >=0.5;

2. Direct body fat measurement shows significantly elevated body fat percentage (>=25% for adult males and >=30% for adult females), which can be measured by bioelectrical impedance analysis (BIA), dual-energy X-ray absorptiometry (DEXA), or other methods;

•3. Clinically diagnosed with chronic kidney disease (CKD), and meet all of the following:

1. At least 2 consecutive documented UACR values >30 mg/g within 12 weeks prior to screening; UACR ranges from 100 to 3500 mg/g (11.4-395.9 mg/mmol) at screening;

2. eGFR >=25 mL/min/1.73 m^2 at screening (calculated using the CKD-EPI equation);

•4. Stable renal function at screening, defined as a change in eGFR of less than 30% within 12 weeks prior to screening;

•5. Voluntarily sign the informed consent form and be willing to strictly comply with all requirements and restrictions specified in the informed consent form and this protocol throughout the study period.

Exclusion criteria

•1. Known allergy to the study drug (active ingredients or excipients) or similar drugs.

•2. A previous diagnosis of type 1 diabetes mellitus [including latent autoimmune diabetes in adults (LADA)], type 2 diabetes mellitus, or other types of diabetes mellitus; or HbA1c >= 6.5% or fasting blood glucose >= 7.0 mmol/L at screening.

•3. Serum potassium > 5 mmol/L at screening.

•4. Patients with chronic kidney disease (CKD) requiring hormonal or immunosuppressant therapy within 6 months prior to screening.

•5. Mean blood pressure > 160/100 mmHg or mean systolic blood pressure < 90 mmHg at screening.

•6. History of renal transplantation, or acute kidney injury requiring dialysis within 24 weeks prior to the screening visit.

•7. Occurrence of any acute cardiovascular or cerebrovascular events within 12 weeks prior to screening, including decompensated heart failure, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective percutaneous coronary intervention, or coronary artery bypass grafting.

•8. Prior treatment with mineralocorticoid receptor antagonists (MRAs) (e.g., finerenone, eplerenone, esaxerenone, spironolactone, canrenone) or renin inhibitors within 8 weeks prior to screening.

•9. Prior treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) within 8 weeks prior to screening.

•10. Ongoing or planned treatment with potassium supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), or potassium-binding agents within 8 weeks prior to screening.

•11. Use of traditional Chinese medicines that may affect urinary protein excretion.

•12. Receiving continuous treatment with strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or moderate CYP3A4 inducers (e.g., efavirenz) that cannot be discontinued, with no drug washout for at least 7 days prior to randomization.

•13. Hepatic insufficiency (Child-Pugh Class C).

•14. Addison's disease.

•15. Symptomatic heart failure with reduced ejection fraction that requires MRA administration as standard therapy.

•16. Uncontrolled thyroid disease at screening (defined as TSH > 6.0 mIU/L or < 0.4 mIU/L), personal or family history of medullary thyroid carcinoma, or diagnosis of multiple endocrine neoplasia type 2 syndrome.

•17. History of acute pancreatitis within 24 weeks prior to screening, or current chronic pancreatitis.

•18. Participation in any other interventional clinical trial or use of any investigational product within 12 weeks prior to randomization.

•19. History of alcohol or substance abuse.

•20. Females of childbearing potential who are pregnant, breastfeeding, intend to become pregnant during the study period, or fail to adopt effective contraceptive measures.

•21. Any other medical conditions that, in the investigator's judgment, may interfere with the efficacy or safety assessment of the study and make the subject inappropriate for study participation.

Endpoints (26)

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

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

MASH / liver

Safety / tolerability / PK

Heart failure

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist-to-Height Ratio

Time frame:Baseline to Week 24

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Other/protocol endpoint

Change From Baseline in Homeostasis Model Assessment 2 of Insulin Resistance (HOMA2-IR)

Time frame:Baseline to Week 24

change from baseline, improvement

Other/protocol endpoint

Participants With New-onset Diabetes

Time frame:Baseline through Week 28

descriptive

MASH / liver

2 endpoints

Other/protocol endpoint

Change From Baseline in Fibrosis-4 Index (FIB-4)

Time frame:Baseline to Week 24

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Liver Stiffness Measurement

Time frame:Baseline to Week 24

change from baseline, improvement

Heart failure

1 endpoint

Secondary/protocol endpoint

Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)

Time frame:Baseline to Week 24

change from baseline, improvement

Renal / kidney

8 endpoints

Primary/protocol endpoint

Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants With UACR <30 mg/g at Week 24

Time frame:Baseline to Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving a ≥30%, ≥40%, or ≥50% Reduction in UACR from Baseline

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants With Regression of Albuminuria Category

Time frame:Baseline to Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Creatinine-based Estimated Glomerular Filtration Rate (Cr-eGFR)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Cystatin C-based Estimated Glomerular Filtration Rate (Cys-C-eGFR)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Estimated Glomerular Filtration Rate Slope Through Week 24

Time frame:Baseline through Week 24

ratio, improvement

Other/protocol endpoint

Participants With Early eGFR Decline

Time frame:Baseline to Week 4

descriptive

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Serum Uric Acid

Time frame:Baseline to Week 24

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Participants With Serious Adverse Events

Time frame:From first dose through 30 days after the last dose

descriptive

Other/protocol endpoint

Participants With Treatment-emergent Adverse Events

Time frame:From first dose through Week 24

descriptive

Other (unclassified)

3 endpoints

Other/protocol endpoint/low confidence

Participants With Hyperkalemia

Time frame:From first dose through Week 24

descriptive

Other/protocol endpoint/low confidence

Participants With Severe Hyperkalemia

Time frame:From first dose through Week 24

descriptive

Other/protocol endpoint/low confidence

Change From Baseline in Serum Potassium

Time frame:Baseline to Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.