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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 30 Years and 84 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EDG-15400 25 mg
  • Drug: EDG-15400 25 mg
    EDG-15400 administered orally, once daily
Experimental
EDG-15400 50 mg
  • Drug: EDG-15400 50 mg
    EDG-15400 administered orally, once daily
Placebo Comparator
Placebo
  • Drug: Placebo to match EDG-15400 25 mg or 50 mg
    Placebo administered orally, once daily

Recruiting Locations

Local Institution - 149
Vista, California 92081

More Details

Status
Recruiting
Sponsor
Edgewise Therapeutics, Inc.

Study Contact

Study Director: Medical Director, Edgewise Therapeutics, Inc.
720-262-7002
hfstudies@edgewisetx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.