NCT07795814 · Edgewise Therapeutics, Inc.
A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
(EQUINOX)
What this study is about
This is a Phase 2 compared against an inactive treatment study to evaluate the safety and how well patients handle the treatment of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).
View original scientific description
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).
Interventions
DRUG
EDG-15400 25 mg
EDG-15400 administered orally, once daily
DRUG
Placebo to match EDG-15400 25 mg or 50 mg
Placebo administered orally, once daily
DRUG
EDG-15400 50 mg
EDG-15400 administered orally, once daily
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and nonpregnant females, ages ≥30 to \<85 years of age at screening
- Body weight ≥ 45 kg, BMI \< 40
- 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
- Birmingham, Alabama
- Beverly Hills, California
- San Diego, California
- Vista, California
- Peoria, Illinois
- Indianapolis, Indiana
- Cynthiana, Kentucky
- Houma, Louisiana
- Baltimore, Maryland
- Ypsilanti, Michigan
- Jackson, Mississippi
- Kansas City, Missouri
And 11 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations