Heart Failure With Preserved Ejection FractionPhase 2EQUINOXNCT07795814
A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
A Phase 2 study testing EDG-15400 25 mg and EDG-15400 50 mg in people with Heart Failure With Preserved Ejection Fraction, run by Edgewise Therapeutics, Inc. at 28 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 84 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- EDG-15400 25 mg and EDG-15400 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 28 sitesUnited States
- Study dates
- 25 Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Director: Medical Director, Edgewise Therapeutics, Inc. contact
28 sites in 1 country
United States28 sites, 28 recruiting
- Not yet recruiting
Local Institution - 8
Baltimore, Maryland, 21287
- Not yet recruiting
Local Institution - 2
Beverly Hills, California, 90211
- Recruiting
Local Institution - 1
Birmingham, Alabama, 35211
- Not yet recruiting
Local Institution - 17
Charleston, South Carolina, 29425
- Not yet recruiting
Local Institution - 22
Charlottesville, Virginia, 22908
- Not yet recruiting
Local Institution - 15
Cincinnati, Ohio, 45219
- Not yet recruiting
Local Institution - 18
Dallas, Texas, 75390
- Not yet recruiting
Local Institution - 26
Fort Wayne, Indiana, 46804
- Not yet recruiting
Local Institution - 24
Gainesville, Florida, 32608
- Not yet recruiting
Local Institution - 14
Greensboro, North Carolina, 27401
- Recruiting
Local Institution - 7
Houma, Louisiana, 70360
- Not yet recruiting
Local Institution - 19
Houston, Texas, 77030
- Not yet recruiting
Local Institution - 20
Houston, Texas, 77030
- Not yet recruiting
Local Institution - 21
Houston, Texas, 77030
- Not yet recruiting
Local Institution - 6
Indianapolis, Indiana, 46260
- Not yet recruiting
Local Institution - 10
Jackson, Mississippi, 39216
- Not yet recruiting
Local Institution - 11
Kansas City, Missouri, 64131
- Not yet recruiting
Local Institution - 25
Little Rock, Arkansas, 72205
- Not yet recruiting
Local Institution - 16
Mechanicsburg, Pennsylvania, 17050
- Not yet recruiting
Local Institution - 28
Minneapolis, Minnesota, 55407
- Not yet recruiting
Local Institution - 13
New York, New York, 10019
- Recruiting
Local Institution - 5
Peoria, Illinois, 61636
- Not yet recruiting
Local Institution - 3
San Diego, California, 92037
- Not yet recruiting
Local Institution - 23
Seattle, Washington, 98101
- Not yet recruiting
Local Institution - 12
St Louis, Missouri, 63130
- Not yet recruiting
Local Institution - 27
Tulsa, Oklahoma, 74104
- Recruiting
Local Institution - 4
Vista, California, 92081
- Not yet recruiting
Local Institution - 9
Ypsilanti, Michigan, 48197
About this study
Official title: 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
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).
- Being tested
- EDG-15400 25 mg, Placebo to match EDG-15400 25 mg or 50 mg, EDG-15400 50 mg
- Keywords
- Heart failure with preserved ejection fraction, HFpEF, heart failure, EDG-15400
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDG-15400 25 mgDrug
EDG-15400 administered orally, once daily
Placebo to match EDG-15400 25 mg or 50 mgDrug
Placebo administered orally, once daily
EDG-15400 50 mgDrug
EDG-15400 administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| EDG-15400 25 mg | Experimental | Not described Receives: Drug: EDG-15400 25 mg |
| EDG-15400 50 mg | Experimental | Not described Receives: Drug: EDG-15400 50 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo to match EDG-15400 25 mg or 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline through study completion (up to 20 weeks).
Secondary outcomes (2)
Change in Biomarkers
Change from baseline values in NT-proBNP and hs-cTnI
Measured: From baseline through study completion (up to 20 weeks).
EDG-15400 Plasma Concentrations
Observed pre and post-dose plasma concentrations measured throughout the study.
Measured: From baseline through study completion (up to 20 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start25 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795814
- Sponsor's protocol ID
- EDG-15400-201
- Acronym
- EQUINOX
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07795814
- Acronym / sponsor ID
- EQUINOX / EDG-15400-201
- Keywords
- Heart failure with preserved ejection fraction, HFpEF, heart failure, EDG-15400
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDG-15400 25 mg | Experimental | Drug: EDG-15400 25 mg |
| EDG-15400 50 mg | Experimental | Drug: EDG-15400 50 mg |
| Placebo | Placebo comparator | Drug: Placebo to match EDG-15400 25 mg or 50 mg |
Who may qualify
- Ages
- 30 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDG-15400 25 mgEDG-15400 administered orally, once daily | Drug | EDG-15400 25 mg |
| Placebo to match EDG-15400 25 mg or 50 mgPlacebo administered orally, once daily | Drug | Placebo |
| EDG-15400 50 mgEDG-15400 administered orally, once daily | Drug | EDG-15400 50 mg |
Primary outcome
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
2 secondary outcomes
Change in Biomarkers
Time frame: From baseline through study completion (up to 20 weeks).
EDG-15400 Plasma Concentrations
Time frame: From baseline through study completion (up to 20 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director: Medical Director, Edgewise Therapeutics, Inc. contact
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDG-15400 25 mg and EDG-15400 50 mg in people with Heart Failure With Preserved Ejection Fraction, run by Edgewise Therapeutics, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director: Medical Director, Edgewise Therapeutics, Inc. (720-262-7002, hfstudies@edgewisetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From baseline through study completion (up to 20 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.