NCT07795814 A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
| NCT ID | NCT07795814 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Edgewise Therapeutics, Inc. |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-08-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2026-08-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Study Director: Medical Director, Edgewise Therapeutics, Inc.
✉ hfstudies@edgewisetx.com📞 720-262-7002
Frequently Asked Questions
Who can join the NCT07795814 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 84 Years, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07795814 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07795814 currently recruiting?
Yes, NCT07795814 is actively recruiting participants. Contact the research team at hfstudies@edgewisetx.com for enrollment information.
Where is the NCT07795814 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Beverly Hills, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT07795814 clinical trial?
NCT07795814 is sponsored by Edgewise Therapeutics, Inc.. The trial plans to enroll 90 participants.
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