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A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
RecruitingPhase 2
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction
Who can join
Ages 30 to 84 · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- EDG-15400 25 mg (drug)
- Placebo to match EDG-15400 25 mg or 50 mg (drug)
- EDG-15400 50 mg (drug)
Sponsor: Edgewise Therapeutics, Inc. · Participants: 90 · Started: Aug 25, 2026
Contact the study team
- Study Director: Medical Director, Edgewise Therapeutics, Inc. · Phone: 720-262-7002
Official record on ClinicalTrials.gov — NCT07795814
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.