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Drug duo aims to tackle high blood pressure in obesity

NCT ID NCT07678151

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether combining two medications, empagliflozin and finerenone, can lower blood pressure in adults with obesity and stage 1 hypertension. Participants take the drugs or a placebo daily for 12 weeks. The trial also measures effects on kidney function, inflammation, blood sugar, weight, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empagliflozin and finerenone
What this could lead to
If successful, this combination could offer a new treatment option for people with obesity and high blood pressure, potentially providing better heart and kidney protection than current therapies.
What could go wrong
This is a 12-week trial with 260 participants, so results are preliminary. The combination may cause side effects like high potassium, kidney injury, low blood pressure, or low blood sugar.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Ruyang County People's Hospital

    Luoyang, China

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