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

ConditionHypertension (HTN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorHeart Health Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Change in Unattended Office Diastolic Blood Pressure From Baseline to Week 12

Time frame
Baseline (Day 1) to Week 12 (visit 5)
2

Change in Cumulative Blood Pressure Exposure From Baseline to Week 12

Time frame
Baseline (Day 1) to Week 12 (visit 5)
3

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

Time frame
Baseline (Day 1) to Week 12 (visit 5)
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Health Research Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: