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Clinical Trials in the USA / NCT07795814
Recruiting Phase 2

A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)

NCT07795814 · tracked via the Priya Life Science USA tracker
Sponsor
Edgewise Therapeutics, Inc.
Phase
Phase 2
Started
2026-08-25
Last updated
2026-08-31

Condition(s) studied

Heart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

EDG-15400 25 mgPlacebo to match EDG-15400 25 mg or 50 mgEDG-15400 50 mg

EDG-15400 25 mg: EDG-15400 administered orally, once daily

Placebo to match EDG-15400 25 mg or 50 mg: Placebo administered orally, once daily

EDG-15400 50 mg: EDG-15400 administered orally, once daily

Study summary

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).

Eligibility

Sex
ALL
Min age
30 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria: * Males and nonpregnant females, ages ≥30 to \<85 years of age at screening * Body weight ≥ 45 kg, BMI \< 40 * LVEF ≥ 50% * Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure * New York Heart Association (NYHA) functional class II or III * If receiving Guideline-directed Medical Therapy, must be on stable doses * Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study Exclusion Criteria: * Known diagnosis of hypertrophic cardiomyopathy (HCM) * Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis) * Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy * Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy * Hospitalization for any reason within 60 days prior to Screening * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Local Institution - 156 Birmingham Alabama Not Yet Recruiting
Local Institution - 162 Beverly Hills California Not Yet Recruiting
Local Institution - 120 San Diego California Not Yet Recruiting
Local Institution - 149 Vista California Recruiting
Local Institution - 153 Peoria Illinois Not Yet Recruiting
Local Institution - 166 Indianapolis Indiana Not Yet Recruiting
Local Institution - 160 Cynthiana Kentucky Not Yet Recruiting
Local Institution - 155 Houma Louisiana Not Yet Recruiting
Local Institution - 106 Baltimore Maryland Not Yet Recruiting
Local Institution - 158 Ypsilanti Michigan Not Yet Recruiting
Local Institution - 164 Jackson Mississippi Not Yet Recruiting
Local Institution - 145 Kansas City Missouri Not Yet Recruiting
Local Institution - 109 St Louis Missouri Not Yet Recruiting
Local Institution - 154 New York New York Not Yet Recruiting
Local Institution - 159 Greensboro North Carolina Not Yet Recruiting
Local Institution - 129 Cincinnati Ohio Not Yet Recruiting
Local Institution - 165 Mechanicsburg Pennsylvania Not Yet Recruiting
Local Institution - 124 Pittsburgh Pennsylvania Not Yet Recruiting
Local Institution - 142 Charleston South Carolina Not Yet Recruiting
Local Institution - 167 Dallas Texas Not Yet Recruiting
Local Institution - 151 Houston Texas Not Yet Recruiting
Local Institution - 157 Houston Texas Not Yet Recruiting
Local Institution - 163 Houston Texas Not Yet Recruiting
Local Institution - 143 Charlottesville Virginia Not Yet Recruiting
Local Institution - 132 Seattle Washington Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07795814 on ClinicalTrials.gov ↗ ← All trials in the USA