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

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.

What this study is about