For Healthcare Providers

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

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).

Objectives and Endpoints

Primary

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF	From baseline through study completion

Secondary

Outcome Measure	Measure Description	Time Frame
Change in Biomarkers	Change from baseline values in NT-proBNP and hs-cTnI	From baseline through study completion
EDG-15400 Plasma Concentrations	Observed pre and post-dose plasma concentrations measured throughout the study.	From baseline through study completion

Current Enrollment Opportunities

Individuals with the below criteria are being sought for enrollment.

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.

This is intended as a reference for HCPs only and should not be distributed to patients

If you have any patients in your practice who may be eligible to participate in the EQUINOX-HFpEF Study, we encourage you to contact a study site.

Study Schedule

Randomized, double-blind, placebo-controlled, parallel dosing (once-daily, oral dosing for 12 weeks)

Screening Period

EDG-15400: 50 mg

EDG-15400: 25 mg

PLACEBO

Follow-up Period

Screening

Week 0

Week 4

Week 8

Week 12

End of Study

Study Visits