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NCT Number: NCT07795814

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).

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Key information

Age range

30 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 156, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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 outcomes

  1. Change in Biomarkers

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

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

  2. EDG-15400 Plasma Concentrations

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director: Medical Director, Edgewise Therapeutics, Inc.

CONTACT

[email protected]

720-262-7002

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction

Acronym: EQUINOX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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