This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate whether starting finerenone together with semaglutide provides an additional reduction in urinary albumin-to-creatinine ratio compared with semaglutide plus matching placebo in adults in China with obesity, albuminuric chronic kidney disease, and without diabetes. Approximately 266 participants will be randomized in a 1:1 ratio. The treatment period will last 24 weeks, followed by a 4-week off-treatment follow-up period.
1. Age >=18 years at the time of signing the informed consent form, without gender restriction;
BMI >=28 kg/m² 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;
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;
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.
Parallel
Finerenone
DrugOral finerenone once daily for 24 weeks. Starting dose is 10 mg for eGFR 25 to \<60 mL/min/1.73 m2 and 20 mg for eGFR \>=60 mL/min/1.73 m2, with protocol-defined adjustment based on serum potassium and eGFR.
Finerenone Placebo
DrugOral matching placebo once daily for 24 weeks, with tablet number and protocol-defined adjustment procedures matched to finerenone.
Semaglutide
DrugSubcutaneous semaglutide once weekly: 0.25 mg for Weeks 1-4, 0.5 mg for Weeks 5-8, 1.0 mg for Weeks 9-12, 1.7 mg for Weeks 13-16, and 2.4 mg from Week 17 through Week 24, or the maximum tolerated dose.
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24
Proportion of Participants With UACR <30 mg/g at Week 24
Percentage of participants meeting the protocol-defined albuminuria remission threshold.
Proportion of Participants Achieving a ≥30%, ≥40%, or ≥50% Reduction in UACR from Baseline
Percentage of participants with a reduction in UACR of at least 30%, 40%, or 50% from baseline.
Proportion of Participants With Regression of Albuminuria Category
Regression is defined as a change from UACR \>=300 mg/g to 30-299 mg/g, or from UACR 30-299 mg/g to \<30 mg/g.
Change From Baseline in Creatinine-based Estimated Glomerular Filtration Rate (Cr-eGFR)
Cr-eGFR will be calculated using the CKD-EPI equation.
Participants With Serious Adverse Events
Number and percentage of participants with adverse events occurring during the treatment period.
Participants With Treatment-emergent Adverse Events
Number and percentage of participants with serious adverse events.
Participants With Hyperkalemia
Number and percentage of participants with serum potassium \>5.5 mmol/L.
Participants With Severe Hyperkalemia
Number and percentage of participants with serum potassium \>6.0 mmol/L.
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Peking University People's Hospital
Lead sponsor
Daqing Oil Field Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Second Affiliated Hospital of Qiqihar Medical University
Collaborator
Capital Medical University
Collaborator
Huai'an Fifth People's Hospital
Collaborator
Heilongjiang Provicial Hospital
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
Shenzhen University General Hospital
Collaborator
Qiqihar First People's Hospital
Collaborator
Zibo Central Hospital
Collaborator
Hebei General Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Yan'an University Affiliated Hospital
Collaborator
Tianjin People's Hospital
Collaborator
The First Hospital of Hebei Medical University
Collaborator
Daqing Longnan Hospital
Collaborator
Bayer Healthcare Co., Ltd.
Collaborator
Luoyang First People's Hospital
Collaborator
Beijing Pinggu District Hospital
Collaborator
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