RecruitingRecruiting
A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
NCT07795814 · Edgewise Therapeutics, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this 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).
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
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-08-25
Estimated completion: 2027-12
Last updated: 2026-08-31
Interventions
Drug: EDG-15400 25 mgDrug: Placebo to match EDG-15400 25 mg or 50 mgDrug: EDG-15400 50 mg
Primary outcomes
- • Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From baseline through study completion (up to 20 weeks))
Sponsor
Edgewise Therapeutics, Inc. · industry
Contacts & investigators
ContactStudy Director: Medical Director, Edgewise Therapeutics, Inc. · contact · hfstudies@edgewisetx.com · 720-262-7002
All locations (25)
Local Institution - 156Not Yet Recruiting
Birmingham, Alabama, United States
Local Institution - 162Not Yet Recruiting
Beverly Hills, California, United States
Local Institution - 120Not Yet Recruiting
San Diego, California, United States
Local Institution - 149Recruiting
Vista, California, United States
Local Institution - 153Not Yet Recruiting
Peoria, Illinois, United States
Local Institution - 166Not Yet Recruiting
Indianapolis, Indiana, United States
Local Institution - 160Not Yet Recruiting
Cynthiana, Kentucky, United States
Local Institution - 155Not Yet Recruiting
Houma, Louisiana, United States
Local Institution - 106Not Yet Recruiting
Baltimore, Maryland, United States
Local Institution - 158Not Yet Recruiting
Ypsilanti, Michigan, United States
Local Institution - 164Not Yet Recruiting
Jackson, Mississippi, United States
Local Institution - 145Not Yet Recruiting
Kansas City, Missouri, United States
Local Institution - 109Not Yet Recruiting
St Louis, Missouri, United States
Local Institution - 154Not Yet Recruiting
New York, New York, United States
Local Institution - 159Not Yet Recruiting
Greensboro, North Carolina, United States
Local Institution - 129Not Yet Recruiting
Cincinnati, Ohio, United States
Local Institution - 165Not Yet Recruiting
Mechanicsburg, Pennsylvania, United States
Local Institution - 124Not Yet Recruiting
Pittsburgh, Pennsylvania, United States
Local Institution - 142Not Yet Recruiting
Charleston, South Carolina, United States
Local Institution - 167Not Yet Recruiting
Dallas, Texas, United States
Local Institution - 151Not Yet Recruiting
Houston, Texas, United States
Local Institution - 157Not Yet Recruiting
Houston, Texas, United States
Local Institution - 163Not Yet Recruiting
Houston, Texas, United States
Local Institution - 143Not Yet Recruiting
Charlottesville, Virginia, United States
Local Institution - 132Not Yet Recruiting
Seattle, Washington, United States