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RecruitingPhase 2

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

Edgewise Therapeutics, Inc. · NCT07795814

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–84 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
90
US sites recruiting
4
Study start
August 25, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: EDG-15400 25 mg; Placebo to match EDG-15400 25 mg or 50 mg; EDG-15400 50 mg

Conditions: Heart Failure With Preserved Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Study Director: Medical Director, Edgewise Therapeutics, Inc. · 720-262-7002 · hfstudies@edgewisetx.com
A Study of EDG-15400 in Adults With Heart Failure With Preserved… (NCT07795814) | Bored Studies