A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
EQUINOX
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction
1 other identifier
interventional
90
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2026
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2026
CompletedFirst Submitted
Initial submission to the registry
August 26, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 31, 2026
August 1, 2026
1.3 years
August 26, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF
From baseline through study completion (up to 20 weeks)
Secondary Outcomes (2)
Change in Biomarkers
From baseline through study completion (up to 20 weeks)
EDG-15400 Plasma Concentrations
From baseline through study completion (up to 20 weeks)
Study Arms (3)
EDG-15400 25 mg
EXPERIMENTALEDG-15400 50 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Local Institution - 156
Birmingham, Alabama, 35211, United States
Local Institution - 162
Beverly Hills, California, 90211, United States
Local Institution - 120
San Diego, California, 92037, United States
Local Institution - 149
Vista, California, 92081, United States
Local Institution - 153
Peoria, Illinois, 61636, United States
Local Institution - 166
Indianapolis, Indiana, 46260, United States
Local Institution - 160
Cynthiana, Kentucky, 41031, United States
Local Institution - 155
Houma, Louisiana, 70360, United States
Local Institution - 106
Baltimore, Maryland, 21287, United States
Local Institution - 158
Ypsilanti, Michigan, 48197, United States
Local Institution - 164
Jackson, Mississippi, 39216, United States
Local Institution - 145
Kansas City, Missouri, 64131, United States
Local Institution - 109
St Louis, Missouri, 63130, United States
Local Institution - 154
New York, New York, 10019, United States
Local Institution - 159
Greensboro, North Carolina, 27401, United States
Local Institution - 129
Cincinnati, Ohio, 45219, United States
Local Institution - 165
Mechanicsburg, Pennsylvania, 17050, United States
Local Institution - 124
Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 142
Charleston, South Carolina, 29425, United States
Local Institution - 167
Dallas, Texas, 75390, United States
Local Institution - 151
Houston, Texas, 77030, United States
Local Institution - 157
Houston, Texas, 77030, United States
Local Institution - 163
Houston, Texas, 77030, United States
Local Institution - 143
Charlottesville, Virginia, 22908, United States
Local Institution - 132
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Director: Medical Director, Edgewise Therapeutics, Inc.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2026
First Posted
August 31, 2026
Study Start
August 25, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 31, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share