A Phase 4 interventional study of Enavogliflozin 0.3mg and Placebo in Amyloid Cardiomyopathy, sponsored by Seoul St. Mary's Hospital. Recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Seoul St. Mary's Hospital · Phase 4, Interventional, and Treatment
Among 10 studies in Amyloid Neuropathies, Familial with a site in Korea, Republic of — 4 open to participants now, 5 under way, 2 of them phase 3. Amyloid Neuropathies, Familial · Korea, Republic of.
Among the 10 studies in Amyloid Neuropathies, Familial with a site in Korea, Republic of, this one is one of 2 that started in 2026, is the only one in phase 4, and was the 9th registered.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
This study's planned enrollment of 68 is above the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →4 of the 10 studies in Amyloid Neuropathies, Familial with a site in Korea, Republic of are open now.
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2026.
Median enrollment 225 across the 9 interventional studies, 30 across the 1 observational. Of the 4 that completed or were terminated, 3 (75%) have results posted.
5 of 10 have an industry lead sponsor. The 5 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 1 study filed under Amyloid Neuropathies, Familial — fewer than ten, so there is no comparison to draw.
1 of the studies in Amyloid Neuropathies, Familial with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07240844Seoul St. Mary's HospitalEnavogliflozin for the Management of Patients With Amyloid CardiomyopaThy | 2027-04-29 |
Among the 10 studies in Amyloid Neuropathies, Familial with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.
Patients with a confirmed diagnosis of cardiac amyloidosis and symptomatic heart failure (NYHA class II-III) will be recruited.
Participants will be randomized to receive either the study drug or placebo and will undergo baseline and 12-week assessments, including the Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test, and cardiopulmonary exercise testing. Following a 4-week washout period, participants will cross over to the alternate treatment arm (study drug or placebo) and repeat the same assessments at baseline and 12 weeks.
The primary endpoint will be the change in KCCQ Clinical Summary Score (KCCQ-CSS).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administer Enavogliflozin 0.3 mg
Drug: Enavogliflozin 0.3mg
Administer placebo
Drug: Placebo
Participants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
Participants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
Change in KCCQ-CSS from baseline to Week 12
Change in the Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) from baseline to 12 weeks after treatment initiation. The KCCQ-CSS is a patient-reported outcome measure that assesses symptom frequency and physical limitation in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better symptom status and physical function (i.e., better health status). A higher change from baseline reflects an improvement in clinical status.
Time frame: Baseline and Week 12
Change in 6-Minute Walk Distance
Change in distance walked in 6 minutes from baseline to Week 12. Higher distance indicates better exercise capacity.
Time frame: Baseline and Week 12
Change in log-transformed NT-proBNP levels
Change in log-transformed NT-proBNP levels after 12 weeks of treatment compared to baseline
Time frame: Baseline and Week 12
Change in Body Weight
Change in body weight in kilograms from baseline to Week 12
Time frame: Baseline and Week 12
Change in Body Fat Percentage
Change in body fat percentage from baseline to Week 12
Time frame: Baseline and Week 12
Change in Extracellular Water Ratio
Change in the ratio of extracellular water to total body water from baseline to Week 12
Time frame: Baseline and Week 12
Incidence of Worsening Heart Failure Events or Death
Occurrence of worsening heart failure events (defined as emergency outpatient visit or unplanned hospitalization due to heart failure) or death
Time frame: From baseline to Week 12 during each treatment period (excluding the 4-week washout period)
Change in maximal oxygen consumption (VO₂ max)
Change in VO₂ max measured by cardiopulmonary exercise testing (CPET) from baseline to Week 12. Higher values indicate better cardiorespiratory fitness.
Time frame: Baseline and Week 12
Plan to share: Yes — After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Supporting information: Study protocol, Clinical study report
Time frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Access criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Started Jan 2026 (actual). Primary completion is estimated for Apr 2027, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Enavogliflozin
Amyloid Neuropathies, Familial →
Seoul St. Mary's Hospital