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Can a once-daily pill ease the burden of a common heart failure?

NCT ID NCT07795814

Disease control Sponsor: Edgewise Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether EDG-15400, an oral drug taken once daily, can safely improve symptoms and heart function in adults with heart failure with preserved ejection fraction (HFpEF). Participants receive either EDG-15400 or a placebo for a period of time, while researchers monitor side effects and measure changes in heart-related biomarkers. The study includes about 90 adults aged 30 to 85 with a confirmed HFpEF diagnosis and moderate symptoms. The goal is to see if this drug can become a new treatment option for this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EDG-15400, an oral drug taken once daily
What this could lead to
If it works, EDG-15400 could offer a new daily treatment to reduce symptoms and improve heart function in people with heart failure with preserved ejection fraction.
What could go wrong
This is an early phase 2 trial with only 90 participants, so the drug may not prove effective or safe in larger groups. Possible side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Local Institution - 106

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Local Institution - 109

    NOT_YET_RECRUITING

    St Louis, Missouri, 63130, United States

  • Local Institution - 120

    NOT_YET_RECRUITING

    San Diego, California, 92037, United States

  • Local Institution - 124

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Local Institution - 129

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Local Institution - 132

    NOT_YET_RECRUITING

    Seattle, Washington, 98101, United States

  • Local Institution - 142

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Local Institution - 143

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Local Institution - 145

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64131, United States

  • Local Institution - 149

    RECRUITING

    Vista, California, 92081, United States

  • Local Institution - 151

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Local Institution - 153

    NOT_YET_RECRUITING

    Peoria, Illinois, 61636, United States

  • Local Institution - 154

    NOT_YET_RECRUITING

    New York, New York, 10019, United States

  • Local Institution - 155

    NOT_YET_RECRUITING

    Houma, Louisiana, 70360, United States

  • Local Institution - 156

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35211, United States

  • Local Institution - 157

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Local Institution - 158

    NOT_YET_RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Local Institution - 159

    NOT_YET_RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Local Institution - 160

    NOT_YET_RECRUITING

    Cynthiana, Kentucky, 41031, United States

  • Local Institution - 162

    NOT_YET_RECRUITING

    Beverly Hills, California, 90211, United States

  • Local Institution - 163

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Local Institution - 164

    NOT_YET_RECRUITING

    Jackson, Mississippi, 39216, United States

  • Local Institution - 165

    NOT_YET_RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • Local Institution - 166

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Local Institution - 167

    NOT_YET_RECRUITING

    Dallas, Texas, 75390, United States

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