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
- Local Institution - 1 · Birmingham, AL 35211More trials in Birmingham
AR
- Local Institution - 25 · Little Rock, AR 72205More trials in Little Rock
CA
- Local Institution - 2 · Beverly Hills, CA 90211More trials in Beverly Hills
- Local Institution - 3 · San Diego, CA 92037More trials in San Diego
- Local Institution - 4 · Vista, CA 92081More trials in Vista
FL
- Local Institution - 24 · Gainesville, FL 32608More trials in Gainesville
IL
- Local Institution - 5 · Peoria, IL 61636More trials in Peoria
IN
- Local Institution - 26 · Fort Wayne, IN 46804More trials in Fort Wayne
- Local Institution - 6 · Indianapolis, IN 46260More trials in Indianapolis
LA
- Local Institution - 7 · Houma, LA 70360More trials in Houma
MD
- Local Institution - 8 · Baltimore, MD 21287More trials in Baltimore
MI
- Local Institution - 9 · Ypsilanti, MI 48197More trials in Ypsilanti
MN
- Local Institution - 28 · Minneapolis, MN 55407More trials in Minneapolis
MO
- Local Institution - 11 · Kansas City, MO 64131More trials in Kansas City
- Local Institution - 12 · St Louis, MO 63130More trials in St Louis
MS
- Local Institution - 10 · Jackson, MS 39216More trials in Jackson
NC
- Local Institution - 14 · Greensboro, NC 27401More trials in Greensboro
NY
- Local Institution - 13 · New York, NY 10019More trials in New York
OH
- Local Institution - 15 · Cincinnati, OH 45219More trials in Cincinnati
OK
- Local Institution - 27 · Tulsa, OK 74104More trials in Tulsa
PA
- Local Institution - 16 · Mechanicsburg, PA 17050More trials in Mechanicsburg
SC
- Local Institution - 17 · Charleston, SC 29425More trials in Charleston
TX
- Local Institution - 18 · Dallas, TX 75390More trials in Dallas
- Local Institution - 19 · Houston, TX 77030More trials in Houston
- Local Institution - 20 · Houston, TX 77030More trials in Houston
- Local Institution - 21 · Houston, TX 77030More trials in Houston
VA
- Local Institution - 22 · Charlottesville, VA 22908More trials in Charlottesville
WA
- Local Institution - 23 · Seattle, WA 98101More trials in Seattle