A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
Recruiting · NCT07795814 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
EDG-15400 25 mgEDG-15400 50 mgPlacebo to match EDG-15400 25 mg or 50 mg
What this trial 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 take part
Age range
30 Years to 84 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
25 locations listed across 18 US states.
- Local Institution - 156 - Birmingham, Alabama, United States
- Local Institution - 162 - Beverly Hills, California, United States
- Local Institution - 120 - San Diego, California, United States
- Local Institution - 149 - Vista, California, United States
- Local Institution - 153 - Peoria, Illinois, United States
- Local Institution - 166 - Indianapolis, Indiana, United States
- Local Institution - 160 - Cynthiana, Kentucky, United States
- Local Institution - 155 - Houma, Louisiana, United States
- Local Institution - 106 - Baltimore, Maryland, United States
- Local Institution - 158 - Ypsilanti, Michigan, United States
- Local Institution - 164 - Jackson, Mississippi, United States
- Local Institution - 145 - Kansas City, Missouri, United States
- Local Institution - 109 - St Louis, Missouri, United States
- Local Institution - 154 - New York, New York, United States
- Local Institution - 159 - Greensboro, North Carolina, United States
- Local Institution - 129 - Cincinnati, Ohio, United States
- Local Institution - 165 - Mechanicsburg, Pennsylvania, United States
- Local Institution - 124 - Pittsburgh, Pennsylvania, United States
- Local Institution - 142 - Charleston, South Carolina, United States
- Local Institution - 167 - Dallas, Texas, United States
- Local Institution - 151 - Houston, Texas, United States
- Local Institution - 157 - Houston, Texas, United States
- Local Institution - 163 - Houston, Texas, United States
- Local Institution - 143 - Charlottesville, Virginia, United States
- Local Institution - 132 - Seattle, Washington, United States