Recruiting
Phase 2

EDG-15400

Sponsor:

Edgewise Therapeutics, Inc.

Code:

NCT07795814

Conditions

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

EDG-15400 25 mg

Placebo to match EDG-15400 25 mg or 50 mg

EDG-15400 50 mg

Study Details

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).

Conditions

Heart Failure With Preserved Ejection Fraction

Study ID

NCT07795814

Start date

Aug 25, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EDG-15400 25 mg

experimental: EDG-15400 50 mg

placebo comparator: Placebo

Interventions

EDG-15400 25 mg

EDG-15400 administered orally, once daily

Placebo to match EDG-15400 25 mg or 50 mg

Placebo administered orally, once daily

EDG-15400 50 mg

EDG-15400 administered orally, once daily

Primary outcome measure

  • Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From baseline through study completion (up to 20 weeks) ]

Central Contacts and Locations

Central contacts

Study Director: Medical Director, Edgewise Therapeutics, Inc.

720-262-7002hfstudies@edgewisetx.com

Locations

Local Institution - 149

Recruiting

Vista, California, United States, 92081

More Information

Sponsor

Edgewise Therapeutics, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Heart failure with preserved ejection fraction
  • HFpEF
  • heart failure
  • EDG-15400

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Edgewise Therapeutics, Inc. on 2026-08-31.