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

RecruitingPhase 2Ages 30 Years - 84 YearsAllEdgewise Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Males and nonpregnant females, ages โ‰ฅ30 to \<85 years of age at screening * Body weight โ‰ฅ 45 kg, BMI \< 40 * LVEF โ‰ฅ 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
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What it tests

  • EDG-15400 25 mg
  • Placebo to match EDG-15400 25 mg or 50 mg
  • EDG-15400 50 mg
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Where

28 sites
Local Institution - 1
Birmingham, United States
Local Institution - 25
Little Rock, United States
Local Institution - 2
Beverly Hills, United States
Local Institution - 3
San Diego, United States
Local Institution - 4
Vista, United States
Local Institution - 24
Gainesville, United States
Local Institution - 5
Peoria, United States
Local Institution - 26
Fort Wayne, United States

โ€ฆand 20 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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