A Phase 2 interventional study of EDG-15400 25 mg and Placebo to match EDG-15400 25 mg or 50 mg in Heart Failure With Preserved Ejection Fraction, sponsored by Edgewise Therapeutics, Inc.. Recruiting at 28 sites in United States. Open to participants aged 30 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Edgewise Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Among 2,156 studies in Heart Failure with a site in United States — 348 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.
Among the 2,156 studies in Heart Failure with a site in United States, this one is the 695th largest by planned enrollment of the 1,600 interventional ones that give a count, is one of 95 that started in 2026, is one of 226 in phase 2, reaches primary completion later than 260 of the 436 other live ones, and was the 2,143rd registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →348 of the 2,156 studies in Heart Failure with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Tufts Medical Center · Sites in United States
Stanford University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 30 Years to 84 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,156 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 312 · Phase 3 177 · Phase 4 139
First in 1983; this study’s year is marked. 95 started in 2026.
This study's planned enrollment of 90 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 65 across the 1,600 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
745 of 2,156 have an industry lead sponsor. The 10 most frequent:
Edgewise Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Edgewise Therapeutics, Inc. has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
136 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Among the 2,156 studies in Heart Failure with a site in United States, from their registry updates:
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This is a Phase 2 placebo-controlled study to evaluate the safety and tolerability of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: EDG-15400 25 mg
Drug: EDG-15400 50 mg
Drug: Placebo to match EDG-15400 25 mg or 50 mg
EDG-15400 administered orally, once daily
Placebo administered orally, once daily
EDG-15400 administered orally, once daily
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF
Time frame: From baseline through study completion (up to 20 weeks).
Change in Biomarkers
Change from baseline values in NT-proBNP and hs-cTnI
Time frame: From baseline through study completion (up to 20 weeks).
EDG-15400 Plasma Concentrations
Observed pre and post-dose plasma concentrations measured throughout the study.
Time frame: From baseline through study completion (up to 20 weeks).
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
Of 73 industry-sponsored phase 2 interventional studies under Heart Failure, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 31. This study's planned 16 months is below that.
Counting every sponsor, half of 184 studies reached it within 29 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Edgewise Therapeutics, Inc.