EDG-15400 in adults with HFpEF: a phase 2 study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled phase 2 trial evaluating the safety and tolerability of EDG-15400 in adults with heart failure and preserved ejection fraction. Participants are assigned to EDG-15400 25 mg, EDG-15400 50 mg, or matching placebo, with follow-up for adverse events and tolerability. Eligibility includes adults aged 30–<85 with LVEF ≥50%, NYHA class II–III, and stable guideline-directed medical therapy if applicable. Exclusion criteria include hypertrophic cardiomyopathy, infiltrative diseases, and significant chronic lung disease. The lead sponsor is Edgewise Therapeutics, with sites in Birmingham, AL; Little Rock, AR; and Beverly Hills, CA.

Why it matters

Who can join: the full rules

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

Where it's running

• Local Institution - 1
  Birmingham, Alabama, United States Recruiting
• Local Institution - 4
  Vista, California, United States Recruiting
• Local Institution - 5
  Peoria, Illinois, United States Recruiting
• Local Institution - 7
  Houma, Louisiana, United States Recruiting
• Local Institution - 25
  Little Rock, Arkansas, United States Not yet recruiting
• Local Institution - 2
  Beverly Hills, California, United States Not yet recruiting

Study contacts

• Study coordinator: Study Director: Medical Director, Edgewise Therapeutics, Inc.
• Email: hfstudies@edgewisetx.com
• Phone: 720-262-7002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

• Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

  This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

  Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.