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

Korábbi kezelés

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

Más betegség

• 1. Known allergy to the study drug (active ingredients or excipients) or similar drugs.
• 13. Hepatic insufficiency (Child-Pugh Class C).
• 14. Addison's disease.
• 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.
• 19. History of alcohol or substance abuse.
• 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.

Laborértékek

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

Egyéb

• 5. Mean blood pressure > 160/100 mmHg or mean systolic blood pressure < 90 mmHg at screening.
• 11. Use of traditional Chinese medicines that may affect urinary protein excretion.
• 20. Females of childbearing potential who are pregnant, breastfeeding, intend to become pregnant during the study period, or fail to adopt effective contraceptive measures.

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