drugset / Trial / NCT07849348
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
Not yet recruiting
266 enrolled
Peking University People's Hospital
Bayer Healthcare Co., Ltd. · collabBeijing Pinggu District Hospital · collabCapital Medical University · collabDaqing Longnan Hospital · collabDaqing Oil Field Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabHebei General Hospital · collabHeilongjiang Provicial Hospital · collabHuai'an Fifth People's Hospital · collabLuoyang First People's Hospital · collabQiqihar First People's Hospital · collabShenzhen University General Hospital · collabSuzhou Municipal Hospital · collabThe First Affiliated Hospital of Henan University of Science and Technology · collabThe First Hospital of Hebei Medical University · collabThe Second Affiliated Hospital of Qiqihar Medical University · collabTianjin People's Hospital · collabYan'an University Affiliated Hospital · collabZibo Central Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2026-09
- Primary completion
- 2027-02
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Finerenone | Small molecule | 10 mg | Oral |
| Subject | Finerenone | Small molecule | 20 mg | Oral |
| Background | Semaglutide | Peptide | 2.4 mg | Subcutaneous |