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

NCT07678151 | Not Yet Recruiting

• 1 other identifier: EFFORT
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief 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 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)

Keywords

Sodium-Glucose Transporter 2 Inhibitors; Mineralocorticoid Receptor Antagonists; Blood Pressure; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Unattended Office Systolic Blood Pressure From Baseline to Week 12

  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

  Baseline (Day 1) to Week 12 (visit 5)

• Change in Cumulative Blood Pressure Exposure From Baseline to Week 12

  Baseline (Day 1) to Week 12 (visit 5)

• Change in Log-Transformed Urinary Albumin-to-Creatinine Ratio From Baseline to Week 12

  Baseline (Day 1) to Week 12 (visit 5)

• Change in High-Sensitivity C-Reactive Protein From Baseline to Week 12

  Baseline (Day 1) to Week 12 (visit 5)

• Change in Fasting Plasma Glucose From Baseline to Week 12

  Baseline (Day 1) to Week 12 (visit 5)

Study Arms (2)

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.

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.

Drug: Placebo for Empagliflozin and Finerenone

Interventions

Empagliflozin and Finerenone DRUG

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.

Intervention group

Placebo for Empagliflozin and Finerenone DRUG

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.

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Health Research Center: lead

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Ruyang County People's Hospital

Luoyang, China

Location

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

empagliflozin; finerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xin Du

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Du, Professor

CONTACT

+8613370103558; duxinheart@sina.com

Rong Han

CONTACT

+86 13910669903; hanrong@hhresearch.cn

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: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (2)