Could a diabetes drug help hearts stiffened by amyloid?
NCT ID NCT07240844
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Enavogliflozin, a drug used for diabetes, can help people with amyloid cardiomyopathy, a condition where abnormal proteins build up in the heart. About 68 adults with heart failure symptoms will take the drug or a placebo for 12 weeks, then switch. The main goal is to see if the drug improves heart-related symptoms and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Enavogliflozin
- What this could lead to
- If it works, this could offer a new treatment option to improve heart function and quality of life in people with amyloid cardiomyopathy.
- What could go wrong
- This is a small, early-phase trial with only 68 participants. The drug may not show significant benefit over placebo, and side effects are possible.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Adults aged 19 years or older 2. Diagnosed with amyloid cardiomyopathy confirmed by cardiac biopsy or non-invasive imaging 3. Presence of heart failure symptoms corresponding to NYHA functional class II-III 4. Patients on stable oral diuretic use, without dose changes exceeding 50% of the previous dose, for at least 2 weeks prior to study enrollment 5. Ambulatory (able to walk) 6. Able to provide written informed consent for study participation Exclusion Criteria: 1. Pregnant or breastfeeding women 2. Active infection 3. Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months 4. Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery 5. History of heart transplantation 6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² (calculated by CKD-EPI formula) 7. No history of cancer within the past 5 years at screening (except borderline cancers without recurrence for 2-3 years; multiple myeloma with cardiac involvement is classified as cardiac amyloidosis and is exempt) 8. Heart failure primarily caused by severe left sided valvular disease or ischemic heart disease (except if valvular disease is corrected) 9. Type 1 diabetes mellitus or insulin-dependent diabetes 10. History of ketoacidosis, complicated urinary or genital infections, or kidney stones 11. Systolic blood pressure \< 80 mmHg or symptomatic hypotension 12. Major surgery within 90 days prior to enrollment 13. Known hypersensitivity or allergic reaction to the study drug or its components 14. Moderate to severe liver impairment 15. Chronic alcohol or substance abuse 16. Residing in long-term care facilities (e.g., nursing homes) 17. Unable to understand or comply with study drug, procedures, or follow-up, or who are deemed by the investigator to be unlikely to complete 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Seoul St. Mary's Hospital, The Catholic University of Korea
RECRUITINGSeoul, 06591, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily pill keep a rare heart disease in check for the long haul?
- Heart drug acoramidis tested for Long-Term cardiac repair in rare amyloidosis
- Nationwide registry aims to crack the code of a rare protein-clogging disease
- Could a diabetes drug ease heart failure in rare amyloid disease?
- Could your lifetime workout routine protect your heart?
- Protein clues could spot rare disease years early