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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.
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

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BaltimoreUnited StatesNot yet recruiting
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Beverly HillsUnited StatesNot yet recruiting
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BirminghamUnited StatesRecruiting
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CharlestonUnited StatesNot yet recruiting
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CharlottesvilleUnited StatesNot yet recruiting
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CincinnatiUnited StatesNot yet recruiting
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DallasUnited StatesNot yet recruiting
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Fort WayneUnited StatesNot yet recruiting
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GainesvilleUnited StatesNot yet recruiting
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GreensboroUnited StatesNot yet recruiting
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HoumaUnited StatesRecruiting
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HoustonUnited StatesNot yet recruiting
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HoustonUnited StatesNot yet recruiting
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HoustonUnited StatesNot yet recruiting
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IndianapolisUnited StatesNot yet recruiting
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JacksonUnited StatesNot yet recruiting
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Kansas CityUnited StatesNot yet recruiting
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Little RockUnited StatesNot yet recruiting
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MechanicsburgUnited StatesNot yet recruiting
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MinneapolisUnited StatesNot yet recruiting
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New YorkUnited StatesNot yet recruiting
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PeoriaUnited StatesRecruiting
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San DiegoUnited StatesNot yet recruiting
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SeattleUnited StatesNot yet recruiting
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St LouisUnited StatesNot yet recruiting
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TulsaUnited StatesNot yet recruiting
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VistaUnited StatesRecruiting
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YpsilantiUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.