Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial

June 25, 2026 updated by: Heart Health Research Center
The EFFORT Study (Empagliflozin and Finerenone Combination in Obesity with Hypertension) is a 12-week, randomized, double-blind, placebo-controlled trial that aims to test whether combining empagliflozin (10 mg/day) with finerenone (10 mg/day, up-titrated to 20 mg after 4 weeks) can significantly lower office systolic blood pressure in adults with obesity and stage 1 hypertension (systolic BP 140-160 mmHg) who are on up to two stable antihypertensives. The study will enroll 260 participants from community settings. Beyond blood pressure, the trial will also assess effects on diastolic pressure, cumulative BP exposure, urinary albumin-to-creatinine ratio, inflammation (hs-CRP), fasting glucose, body weight, and quality of life. Safety monitoring focuses on hyperkalemia, acute kidney injury, hypotension, and hypoglycemia. If positive, this research may offer a new, mechanism-based therapeutic strategy for the growing population with cardiometabolic risk, potentially providing better cardiovascular and kidney protection than conventional approaches.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Luoyang, China
        • Ruyang County People's Hospital
        • Contact:
        • Principal Investigator:
          • Wukun Ma
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Anzhen Hospital, Capital Medical University
        • Principal Investigator:
          • Xin Du
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥ 40 years.

Body mass index (BMI) ≥ 28 kg/m² or abdominal obesity, defined as meeting any of the following:

Waist circumference ≥ 90 cm (male) or ≥ 85 cm (female); Waist-to-hip ratio ≥ 0.9 (male) or ≥ 0.85 (female); Waist-to-height ratio ≥ 0.5. Unattended office systolic blood pressure (SBP) ≥ 140 mmHg and < 160 mmHg during the screening period (within 1 week before randomization).

Currently taking no more than 2 antihypertensive agents (fixed-dose combinations are counted by the number of active ingredients).

No changes in the type or dose of antihypertensive medications within 4 weeks before the screening visit.

Provide written informed consent.

Exclusion Criteria:

Diastolic blood pressure ≥ 100 mmHg. Diagnosed diabetes mellitus or fasting plasma glucose ≥ 7.0 mmol/L. History of heart failure (any ejection fraction) or left ventricular ejection fraction < 50%.

Acute coronary syndrome, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within 90 days.

Stroke or transient ischemic attack (TIA) within 90 days. Known secondary hypertension (e.g., bilateral renal artery stenosis >75%, aldosteronism, pheochromocytoma), except documented sleep apnea.

Severe hepatic dysfunction (AST/ALT > 3× upper limit of normal, or Child-Pugh class C).

Acute kidney injury within 6 months before screening, or eGFR < 60 mL/min/1.73 m², or kidney transplant (or planned).

Primary adrenal insufficiency (Addison's disease). Contraindications to any component of the study drugs (e.g., urinary tract infection within 90 days, serum potassium > 5.0 mmol/L, drug allergy).

Major surgery under general anesthesia within 90 days before screening, or elective surgery planned within 90 days after screening.

Gastrointestinal surgery or disease that, in the investigator's judgment, may affect absorption of the study drug.

Pregnancy, lactation, or planned pregnancy (for both male and female participants) during the study period.

Active malignancy. Life expectancy < 3 months. Use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) or inducers (e.g., rifampicin, carbamazepine, phenytoin) that cannot be discontinued within 7 days before Day 1.

Use of mineralocorticoid receptor antagonists (e.g., finerenone, eplerenone, spironolactone), renin inhibitors, SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), or SGLT-1/2 inhibitors (e.g., canagliflozin) within 8 weeks before screening or during the intervention period.

Use of potassium supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), or potassium-binding agents within 8 weeks before screening or during the intervention period.

Participation in a clinical trial of empagliflozin or finerenone within 1 month before screening.

Current use of weight-loss medications (e.g., GLP-1 receptor agonists, GIP/GLP-1 dual agonists, GLP-1/GCGR dual agonists) or prior/planned bariatric surgery.

Known or suspected orthostatic hypotension or autonomic dysfunction. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participants receive empagliflozin 10 mg oral tablet once daily plus finerenone 10 mg oral tablet once daily for 12 weeks. At Week 4 (visit 3, ±4 days), the finerenone dose may be up-titrated to 20 mg once daily if the following criteria are met: serum potassium ≤4.8 mmol/L and estimated glomerular filtration rate (eGFR) decline <30% from the previous visit's value.
Drug: Empagliflozin and Finerenone
This is a fixed-dose combination of two oral medications-empagliflozin (a sodium-glucose cotransporter 2 inhibitor) and finerenone (a nonsteroidal mineralocorticoid receptor antagonist)-administered simultaneously as separate tablets once daily for 12 weeks. The intervention consists of empagliflozin 10 mg once daily plus finerenone 10 mg once daily, taken orally in the morning with or without food.
Placebo Comparator: Control group
Participants receive matching placebo for empagliflozin 10 mg oral tablet once daily plus matching placebo for finerenone 10 mg oral tablet once daily for 12 weeks. To maintain blinding, a sham up-titration of the finerenone placebo is performed at Week 4 (visit 3, ±4 days) using the same criteria simulation.
Drug: Placebo for Empagliflozin and Finerenone
Participants receive two matching placebo tablets orally once daily in the morning, with or without food, for 12 weeks: one placebo matching empagliflozin 10 mg and one placebo matching finerenone 10 mg. Both placebos are identical in appearance, size, shape, color, and taste to the corresponding active study drugs to ensure complete double-blinding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Unattended Office Systolic Blood Pressure From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5, end-of-treatment visit)
Baseline (Day 1) to Week 12 (visit 5, end-of-treatment visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Unattended Office Diastolic Blood Pressure From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in Cumulative Blood Pressure Exposure From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in Log-Transformed Urinary Albumin-to-Creatinine Ratio From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in High-Sensitivity C-Reactive Protein From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in Fasting Plasma Glucose From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in Body Weight From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Change in EQ-5D Quality of Life Score From Baseline to Week 12
Time Frame: Baseline (Day 1) to Week 12 (visit 5)
Baseline (Day 1) to Week 12 (visit 5)
Proportion of Participants Achieving Strict Blood Pressure Control at Week 12
Time Frame: Week 12 (visit 5)
Week 12 (visit 5)
Proportion of Participants With SBP >160 mmHg or Initiation of Additional Antihypertensive Therapy Within 12 Weeks
Time Frame: Baseline (Day 1) through Week 12 (visit 5)
Baseline (Day 1) through Week 12 (visit 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heart Health Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xin Du, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFFORT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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