RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 84 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests the safety of different doses of EDG-15400 and how well people can tolerate them, compared with a placebo (a treatment with no active drug). It is for adults with heart failure with preserved ejection fraction (HFpEF), meaning the heart still pumps out a normal share of blood with each beat.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 30 to 84 at screening. Women must not be pregnant.
  • Weigh at least 45 kg (about 99 pounds) and have a BMI below 40. BMI is a measure based on height and weight.
  • The heart’s main pumping chamber pumps out at least 50% of its blood with each beat.
  • Have heart failure diagnosed using major heart groups’ guidelines.
  • Have NYHA class II or III heart failure: symptoms limit physical activity, but you are comfortable at rest.
  • If taking guideline-recommended heart failure medicines, doses must be stable.
  • If already taking a GLP-1 medicine before screening, have no plans to change the dose during the study.

Who can't join

  • Have hypertrophic cardiomyopathy, a condition that makes the heart muscle too thick.
  • Have or may have a disorder that causes substances to build up in tissues or affects their growth, such as Noonan syndrome, Fabry disease, or amyloidosis.
  • Have at least moderate interstitial lung disease (damage or scarring in the lungs), or need long-term extra oxygen for it.
  • Have severe or worse COPD (a lung disease that limits airflow), or need long-term extra oxygen for it.
  • Were hospitalized for any reason within 60 days before screening.
  • Have another significant illness, cancer, active infection, or condition that the study doctor believes could explain the heart failure symptoms, make participation unsafe, or interfere with the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (28)

AL

AR

CA

FL

IL

IN

LA

MD

MI

MN

MO

MS

NC

NY

OH

OK

PA

SC

TX

VA

WA