NCT07795814RecruitingPhase 2
A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 25 Aug 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Diseases
- Heart failure
- NCT number
- NCT07795814
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 25 Aug 2026 to the primary completion date, Dec 2027
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalization for any reason within 60 days prior to Screening
Other illness
- 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
- 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
Other
- Known diagnosis of hypertrophic cardiomyopathy (HCM)
Who the study is looking for
- 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
Age in the registry: 30 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.