Hypertension (HTN)NCT07678151
Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial
A study testing Empagliflozin and Finerenone in people with Hypertension (HTN), run by Heart Health Research Center at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Empagliflozin and Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jul 2026to 31 Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Xin Du, +86 13370103558, duxinheart@sina.com
Xin Du
Ruyang County People's Hospital
Luoyang
Wukun Ma, +86 13183087920, 646242109@qq.com
Wukun Ma
About this study
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.
- Conditions
- Hypertension (HTN)
- Being tested
- Empagliflozin and Finerenone, Placebo for Empagliflozin and Finerenone
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Blood Pressure, Obesity
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin and FinerenoneDrug
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 for Empagliflozin and FinerenoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Drug: Empagliflozin and Finerenone |
| Control group | Placebo comparator | 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. Receives: Drug: Placebo for Empagliflozin and Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unattended Office Systolic Blood Pressure From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5, end-of-treatment visit)
Secondary outcomes (9)
Change in Unattended Office Diastolic Blood Pressure From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in Cumulative Blood Pressure Exposure From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in Log-Transformed Urinary Albumin-to-Creatinine Ratio From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in High-Sensitivity C-Reactive Protein From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in Fasting Plasma Glucose From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in Body Weight From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Change in EQ-5D Quality of Life Score From Baseline to Week 12
Measured: Baseline (Day 1) to Week 12 (visit 5)
Proportion of Participants Achieving Strict Blood Pressure Control at Week 12
Measured: Week 12 (visit 5)
Proportion of Participants With SBP >160 mmHg or Initiation of Additional Antihypertensive Therapy Within 12 Weeks
Measured: Baseline (Day 1) through Week 12 (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start13 Jul 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Health Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Du, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678151
- Sponsor's protocol ID
- EFFORT
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07678151
- Acronym / sponsor ID
- EFFORT
- Conditions
- Hypertension (HTN)
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Blood Pressure, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Heart Health Research CenterUniversity, hospital or other
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Jul 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.
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 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 |
|---|---|---|
| Intervention group | Experimental | Drug: Empagliflozin and FinerenoneParticipants 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. |
| Control group | Placebo comparator | Drug: Placebo for Empagliflozin and FinerenoneParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
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 |
|---|---|---|
| Empagliflozin and FinerenoneThis 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. | Drug | Intervention group |
| Placebo for Empagliflozin and FinerenoneParticipants 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. | Drug | Control group |
Primary outcome
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)
9 secondary outcomes
Change in Unattended Office Diastolic Blood Pressure From Baseline to Week 12
Time frame: 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)
Change in Log-Transformed Urinary Albumin-to-Creatinine Ratio From Baseline to Week 12
Time frame: 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)
Change in Fasting Plasma Glucose From Baseline to Week 12
Time frame: 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)
Change in EQ-5D Quality of Life Score From Baseline to Week 12
Time frame: 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)
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)
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 1 Jul 2026.
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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.
Xin Du principal investigator
Beijing Anzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin and Finerenone in people with Hypertension (HTN), run by Heart Health Research Center at 2 sites in China.
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 6 inclusion and 15 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Xin Du, Professor (+8613370103558, duxinheart@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 1 Jul 2026.