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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
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.
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.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Ruyang County People's Hospital
Luoyang, China
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)
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)
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