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

NCT07849348 | Not Yet Recruiting DMC

• 1 other identifier: 2026PHD018-001
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity; Chronic Kidney Disease; Albuminuria

Keywords

Obesity-related chronic kidney disease; Non-diabetic; Albuminuria; Finerenone; Semaglutide; Mineralocorticoid receptor antagonist; GLP-1 receptor agonist; UACR

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 24

Secondary Outcomes (15)

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

  Baseline to Week 24

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

  Baseline to Week 24

• Proportion of Participants With Regression of Albuminuria Category

  Baseline to Week 24

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

  Baseline to Week 24

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

  Baseline to Week 24

Other Outcomes (10)

• Participants With Serious Adverse Events

  From first dose through 30 days after the last dose

• Participants With Treatment-emergent Adverse Events

  From first dose through Week 24

• Participants With Hyperkalemia

  From first dose through Week 24

Study Arms (2)

Finerenone combined with semaglutide injection

EXPERIMENTAL

Drug: Finerenone; Drug: Semaglutide

Finerenone placebo combined with semaglutide injection for intervention

PLACEBO COMPARATOR

Drug: Finerenone Placebo; Drug: Semaglutide

Interventions

Semaglutide DRUG

Subcutaneous 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.

Finerenone combined with semaglutide injection; Finerenone placebo combined with semaglutide injection for intervention

Finerenone DRUG

Oral 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 combined with semaglutide injection

Finerenone Placebo DRUG

Oral matching placebo once daily for 24 weeks, with tablet number and protocol-defined adjustment procedures matched to finerenone.

Finerenone placebo combined with semaglutide injection for intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>=18 years at the time of signing the informed consent form, without gender restriction;
• \. 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;
• \. 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);
• \. Stable renal function at screening, defined as a change in eGFR of less than 30% within 12 weeks prior to screening;
• \. 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.

You may not qualify if:

• \. Known allergy to the study drug (active ingredients or excipients) or similar drugs.
• \. 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.
• \. Serum potassium \> 5 mmol/L at screening.
• \. Patients with chronic kidney disease (CKD) requiring hormonal or immunosuppressant therapy within 6 months prior to screening.
• \. Mean blood pressure \> 160/100 mmHg or mean systolic blood pressure \< 90 mmHg at screening.
• \. History of renal transplantation, or acute kidney injury requiring dialysis within 24 weeks prior to the screening visit.
• \. 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.
• \. Prior treatment with mineralocorticoid receptor antagonists (MRAs) (e.g., finerenone, eplerenone, esaxerenone, spironolactone, canrenone) or renin inhibitors within 8 weeks prior to screening.
• \. Prior treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) within 8 weeks prior to screening.
• \. Ongoing or planned treatment with potassium supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), or potassium-binding agents within 8 weeks prior to screening.
• \. Use of traditional Chinese medicines that may affect urinary protein excretion.
• \. 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.
• \. Hepatic insufficiency (Child-Pugh Class C).
• \. Addison's disease.
• \. Symptomatic heart failure with reduced ejection fraction that requires MRA administration as standard therapy.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Daqing Oil Field Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Capital Medical University: collaborator
• Qiqihar First People's Hospital: collaborator
• Hebei General Hospital: collaborator
• Tianjin People's Hospital: collaborator
• Daqing Longnan Hospital: collaborator
• Bayer Healthcare Co., Ltd.: collaborator
• Beijing Pinggu District Hospital: collaborator
• Huai'an Fifth People's Hospital: collaborator
• Zibo Central Hospital: collaborator
• Yan'an University Affiliated Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator
• Luoyang First People's Hospital: collaborator
• The Second Affiliated Hospital of Qiqihar Medical University: collaborator
• Heilongjiang Provicial Hospital: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator
• Shenzhen University General Hospital: collaborator
• Suzhou Municipal Hospital: collaborator

MeSH Terms

Conditions

Obesity; Renal Insufficiency, Chronic; Albuminuria

Interventions

finerenone; semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Proteinuria; Urination Disorders; Urological Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09