Obesity; Chronic Kidney Disease; AlbuminuriaNCT07849348
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
A study testing Finerenone and Semaglutide in people with Obesity; Chronic Kidney Disease; Albuminuria, run by Peking University People's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity; Chronic Kidney Disease; Albuminuria
- What is being tested?
- Finerenone and Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
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.
Read the detailed description
Eligible participants will be randomized 1:1 to semaglutide plus finerenone or semaglutide plus matching finerenone placebo. Randomization will be stratified by baseline UACR category and BMI category. Semaglutide will be initiated at 0.25 mg once weekly and escalated every 4 weeks to a maximum of 2.4 mg once weekly as tolerated. Finerenone or matching placebo will start at 10 mg or 20 mg once daily according to baseline eGFR, with protocol-defined dose adjustment based on serum potassium and eGFR. The double-blind treatment period is 24 weeks, followed by 4 weeks off treatment. The primary objective is to compare change from baseline in UACR at Week 24. Secondary and other outcomes assess albuminuria response, kidney function, body size, blood pressure, inflammation, metabolic markers, and safety.
- Being tested
- Finerenone, Finerenone Placebo, Semaglutide
- Keywords
- Obesity-related chronic kidney disease; Non-diabetic; Albuminuria; Finerenone; Semaglutide; Mineralocorticoid receptor antagonist; GLP-1 receptor agonist; UACR
- Medical subject headings
- Obesity, Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
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 PlaceboDrug
Oral matching placebo once daily for 24 weeks, with tablet number and protocol-defined adjustment procedures matched to finerenone.
SemaglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone combined with semaglutide injection | Experimental | Not described Receives: Drug: Finerenone; Drug: Semaglutide |
| Finerenone placebo combined with semaglutide injection for intervention | Placebo comparator | Not described Receives: Drug: Finerenone Placebo; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24
Measured: Baseline to Week 24
Secondary outcomes (15)
Proportion of Participants With UACR <30 mg/g at Week 24
Percentage of participants meeting the protocol-defined albuminuria remission threshold.
Measured: Baseline to Week 24
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.
Measured: Baseline to Week 24
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.
Measured: Baseline to Week 24
Change From Baseline in Creatinine-based Estimated Glomerular Filtration Rate (Cr-eGFR)
Cr-eGFR will be calculated using the CKD-EPI equation.
Measured: Baseline to Week 24
Change From Baseline in Cystatin C-based Estimated Glomerular Filtration Rate (Cys-C-eGFR)
Change in Cys-C-eGFR from baseline.
Measured: Baseline to Week 24
Estimated Glomerular Filtration Rate Slope Through Week 24
Rate of change in eGFR over the 24-week treatment period.
Measured: Baseline through Week 24
Change From Baseline in Body Weight
Measured: Baseline to Week 24
Change From Baseline in Waist Circumference
Measured: Baseline to Week 24
Change From Baseline in Body Mass Index (BMI)
Measured: Baseline to Week 24
Change From Baseline in Waist-to-Height Ratio
Measured: Baseline to Week 24
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Measured: Baseline to Week 24
Change From Baseline in Systolic Blood Pressure
Measured: Baseline to Week 24
Change From Baseline in Diastolic Blood Pressure
Measured: Baseline to Week 24
Change From Baseline in Serum Uric Acid
Measured: Baseline to Week 24
Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; Chronic Kidney Disease; AlbuminuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daqing Oil Field Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Second Affiliated Hospital of Qiqihar Medical University, Capital Medical University, Huai'an Fifth People's Hospital, Heilongjiang Provicial Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Shenzhen University General Hospital, Qiqihar First People's Hospital, Zibo Central Hospital, Hebei General Hospital, Suzhou Municipal Hospital, Yan'an University Affiliated Hospital, Tianjin People's Hospital, The First Hospital of Hebei Medical University, Daqing Longnan Hospital, Bayer Healthcare Co., Ltd., Luoyang First People's Hospital, Beijing Pinggu District Hospital
- Responsible party
- Principal investigator, Linong Ji, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849348
- Sponsor's protocol ID
- 2026PHD018-001
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07849348
- Acronym / sponsor ID
- 2026PHD018-001
- Keywords
- Obesity-related chronic kidney disease; Non-diabetic; Albuminuria; Finerenone; Semaglutide; Mineralocorticoid receptor antagonist; GLP-1 receptor agonist; UACR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Daqing Oil Field Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Second Affiliated Hospital of Qiqihar Medical University, Capital Medical University, Huai'an Fifth People's Hospital, Heilongjiang Provicial Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Shenzhen University General Hospital, Qiqihar First People's Hospital, Zibo Central Hospital, Hebei General Hospital, Suzhou Municipal Hospital, Yan'an University Affiliated Hospital, Tianjin People's Hospital, The First Hospital of Hebei Medical University, Daqing Longnan Hospital, Bayer Healthcare Co., Ltd., Luoyang First People's Hospital, Beijing Pinggu District Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants will be randomized 1:1 to semaglutide plus finerenone or semaglutide plus matching finerenone placebo. Randomization will be stratified by baseline UACR category and BMI category. Semaglutide will be initiated at 0.25 mg once weekly and escalated every 4 weeks to a maximum of 2.4 mg once weekly as tolerated. Finerenone or matching placebo will start at 10 mg or 20 mg once daily according to baseline eGFR, with protocol-defined dose adjustment based on serum potassium and eGFR. The double-blind treatment period is 24 weeks, followed by 4 weeks off treatment. The primary objective is to compare change from baseline in UACR at Week 24. Secondary and other outcomes assess albuminuria response, kidney function, body size, blood pressure, inflammation, metabolic markers, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 3. Clinically diagnosed with chronic kidney disease (CKD), and meet all of the following:
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneOral 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. | Drug | Finerenone combined with semaglutide injection |
| Finerenone PlaceboOral matching placebo once daily for 24 weeks, with tablet number and protocol-defined adjustment procedures matched to finerenone. | Drug | Finerenone placebo combined with semaglutide injection for intervention |
| SemaglutideSubcutaneous 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. | Drug | Finerenone combined with semaglutide injection, Finerenone placebo combined with semaglutide injection for intervention |
Primary outcome
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24
Time frame: Baseline to Week 24
15 secondary outcomes
Proportion of Participants With UACR <30 mg/g at Week 24
Time frame: Baseline to Week 24
Proportion of Participants Achieving a ≥30%, ≥40%, or ≥50% Reduction in UACR from Baseline
Time frame: Baseline to Week 24
Proportion of Participants With Regression of Albuminuria Category
Time frame: Baseline to Week 24
Change From Baseline in Creatinine-based Estimated Glomerular Filtration Rate (Cr-eGFR)
Time frame: Baseline to Week 24
Change From Baseline in Cystatin C-based Estimated Glomerular Filtration Rate (Cys-C-eGFR)
Time frame: Baseline to Week 24
Estimated Glomerular Filtration Rate Slope Through Week 24
Time frame: Baseline through Week 24
Change From Baseline in Body Weight
Time frame: Baseline to Week 24
Change From Baseline in Waist Circumference
Time frame: Baseline to Week 24
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline to Week 24
Change From Baseline in Waist-to-Height Ratio
Time frame: Baseline to Week 24
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline to Week 24
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline to Week 24
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline to Week 24
Change From Baseline in Serum Uric Acid
Time frame: Baseline to Week 24
Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Finerenone and Semaglutide in people with Obesity; Chronic Kidney Disease; Albuminuria, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.