Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Heart failure with preserved ejection fraction, HFpEF, heart failure, EDG-15400
Brief summary
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).
Interventions
DRUGEDG-15400 25 mg
EDG-15400 administered orally, once daily
DRUGPlacebo to match EDG-15400 25 mg or 50 mg
Placebo administered orally, once daily
DRUGEDG-15400 50 mg
EDG-15400 administered orally, once daily
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 84 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From baseline through study completion (up to 20 weeks) | Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biomarkers | From baseline through study completion (up to 20 weeks) | Change from baseline values in NT-proBNP and hs-cTnI |
| EDG-15400 Plasma Concentrations | From baseline through study completion (up to 20 weeks) | Observed pre and post-dose plasma concentrations measured throughout the study. |
Countries
United States
Contacts
CONTACTStudy Director: Medical Director, Edgewise Therapeutics, Inc.
Outcome results
None listed