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Accepting PatientsPhase 2 (Efficacy)NCT07795814

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

Heart Failure With Preserved Ejection Fraction

Phase:Phase 2 (Efficacy)
Status:Accepting Patients
Age:30 - 84
Gender:All
Locations:25 sites

What This Study Is About

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).

Who Can Participate

You May Qualify If
  • 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
  • +2 more...
You Cannot Join If
  • Known diagnosis of hypertrophic cardiomyopathy (HCM)
  • Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis)
  • Hospitalization for any reason within 60 days prior to Screening
Discuss With Your Doctor
  • 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
Key Requirements
  • Age 85+ years
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Local Institution - 156 — Birmingham, Alabama
Local Institution - 162 — Beverly Hills, California
Local Institution - 120 — San Diego, California
Show all 25 locations
Local Institution - 149 — Vista, California
Local Institution - 153 — Peoria, Illinois
Local Institution - 166 — Indianapolis, Indiana
Local Institution - 160 — Cynthiana, Kentucky
Local Institution - 155 — Houma, Louisiana
Local Institution - 106 — Baltimore, Maryland
Local Institution - 158 — Ypsilanti, Michigan
Local Institution - 164 — Jackson, Mississippi
Local Institution - 145 — Kansas City, Missouri
Local Institution - 109 — St Louis, Missouri
Local Institution - 154 — New York, New York
Local Institution - 159 — Greensboro, North Carolina
Local Institution - 129 — Cincinnati, Ohio
Local Institution - 165 — Mechanicsburg, Pennsylvania
Local Institution - 124 — Pittsburgh, Pennsylvania
Local Institution - 142 — Charleston, South Carolina
Local Institution - 167 — Dallas, Texas
Local Institution - 151 — Houston, Texas
Local Institution - 157 — Houston, Texas
Local Institution - 163 — Houston, Texas
Local Institution - 143 — Charlottesville, Virginia
Local Institution - 132 — Seattle, Washington

Contact

Contact

Study Director: Medical Director, Edgewise Therapeutics, Inc.

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.