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

ConditionHeart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-84
SponsorEdgewise Therapeutics, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDG-15400 25 mg

    Drug

    EDG-15400 administered orally, once daily

  • Placebo to match EDG-15400 25 mg or 50 mg

    Drug

    Placebo administered orally, once daily

  • EDG-15400 50 mg

    Drug

    EDG-15400 administered orally, once daily

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: EDG-15400 25 mgExperimental treatment 1 intervention
Group B: EDG-15400 50 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline through study completion (up to 20 weeks)

Secondary outcomes

1

Change in Biomarkers

Change from baseline values in NT-proBNP and hs-cTnI

Time frame
From baseline through study completion (up to 20 weeks)
2

EDG-15400 Plasma Concentrations

Observed pre and post-dose plasma concentrations measured throughout the study.

Time frame
From baseline through study completion (up to 20 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edgewise Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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