Effect of elecoglipron plus dapagliflozin on cardiovascular outcomes in adults with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF)
The study looks at adults who have either Heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF). These conditions mean the heart does not pump as well as it should, leading to symptoms like shortness of breath and tiredness. All participants will already be taking a medicine called dapagliflozin, which belongs to a class of drugs that help the kidneys remove extra sugar and fluid. The new drug being tested is Elecoglipron, given as a film‑coated tablet taken by mouth. Some participants will receive a harmless look‑alike tablet called placebo instead of Elecoglipron, so that the effect of the new drug can be compared fairly.
The aim of the trial is to see whether Elecoglipron can lower the chance of cardiovascular death, hospitalization for heart failure (HHF) or an urgent heart failure visit compared with the placebo. Participants will be randomly assigned to one of the two groups and will take the study medication for about one year, with regular check‑ups to record any hospital stays, urgent visits, or other health events such as myocardial infarction (MI) or stroke. The study will track the first occurrence of these events and also count any repeat episodes that happen during the follow‑up period.
1enrollment and baseline assessment
after joining the study, you will sign an informed consent form and undergo initial assessments that may include medical history, physical examination, blood tests, and a questionnaire about your heart condition.
the purpose of these assessments is to record your health status before any study medication is taken.
2randomization to study medication
based on a computer‑generated schedule, you will be assigned to receive either elecoglipron tablets or a matching placebo tablet. the assignment is random and you will not know which one you receive.
all participants will continue to take the background medication forxiga (dapagliflozin) 10 mg once daily.
3start of daily study medication
you will take one tablet of the assigned study medication (elecoglipron or placebo) by mouth each day.
the listed dose for elecoglipron is 00 mg per tablet; the tablet is film‑coated and taken with water.
in addition, you will continue to take forxiga 10 mg once daily, also by mouth.
4regular clinic visits for monitoring
you will attend scheduled visits at the study site, typically at week 4, week 12, week 24, and week 52 after starting the medication.
during each visit, study staff will check your vital signs, review any side effects, collect blood samples, and confirm that you are taking the medication as directed.
5completion of heart‑failure questionnaire
at the initial visit and again at week 52, you will complete a patient‑reported outcome questionnaire that measures how heart failure affects your daily life.
the questionnaire helps researchers understand changes in symptoms over the course of the trial.
6reporting of heart‑failure events
if you are hospitalized for heart failure, have an urgent visit for worsening heart failure, or experience any serious health event, you must inform the study team as soon as possible.
these events are recorded to evaluate the effect of the study medication on cardiovascular outcomes.
7continuation of medication through week 52
you will continue taking the assigned study tablet and forxiga every day for approximately 52 weeks, unless you withdraw consent or the investigator determines that discontinuation is necessary for safety reasons.
8final study visit and end of treatment
at the end of the 52‑week period, you will attend a final visit where final assessments, blood tests, and the last questionnaire will be performed.
after this visit, you will stop taking the study medication and any further follow‑up will be based on standard medical care.
Who Can Join the Study?
Must be at least 18 years old and legally able to give consent when signing the study form.
Must have a heart pumping measurement called left ventricular ejection fraction (LVEF) greater than 40% on a recent heart ultrasound (echocardiogram) or heart MRI, and must have documented signs of heart structure problems within the past year; if recent images are not available, a new ultrasound will be done before joining.
Must show evidence of structural heart disease, which can be any one of the following:
Enlarged upper left heart chamber (left atrial enlargement) meeting study size limits,
Symptoms of heart failure that fit a specific severity range defined by the study.
Must have a blood test result called NT‑proBNP that meets a set level; a higher level is required if the patient has ongoing irregular heartbeat known as atrial fibrillation or flutter.
Must be either walking around (ambulatory) or in the hospital, but must have stopped all intravenous (IV) heart‑failure medicines such as IV diuretics, inotropes, or vasodilators for at least 12 hours before screening; taking medicines by mouth is allowed.
If a patient has never taken a drug called an SGLT2 inhibitor and is hospitalized, they may begin a short “run‑in” with the medication dapagliflozin during the hospital stay, and can be randomized only after they leave the hospital.
Must be able to understand and sign the study’s informed consent form and agree to follow the study rules.
The signed and dated informed consent must be obtained before any study‑specific tests or sample collections are performed.
Who Cannot Join the Study?
Body weight too low: a body‑mass index (BMI) less than 25 kg/m² at the screening visit.
Serious upper stomach or intestinal problems that could change how medicine is absorbed, taking medicines that affect gut movement, or having severe disease or past surgery in that area.
Having had an episode of pancreatitis, which is inflammation of the pancreas, either recent (acute) or long‑term (chronic).
Having a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or multiple endocrine neoplasia type 2 (a hereditary condition that causes tumors), or a blood level of the hormone calcitonin of 35 ng/L or higher at screening.
Having type 1 diabetes (an autoimmune form of diabetes).
Having a hemoglobin A1c (HbA1c) level of 10 % or higher at screening.
Currently being treated, or expected to be treated, for diabetic eye disease such as diabetic retinopathy or macular edema.
Having more than one severe low‑blood‑sugar (hypoglycemia) episode in the past 180 days, or not being able to recognize low‑blood‑sugar symptoms.
Being on dialysis or another form of renal replacement therapy, or having an estimated glomerular filtration rate (eGFR) below the study’s required level at screening.
Having had major heart surgery or procedures (such as coronary artery bypass, heart valve repair or replacement, ablation for irregular heartbeat, cardiac resynchronization therapy, or an implantable cardioverter‑defibrillator without resynchronization) within 90 days before screening, or planning any of these after randomization.
Having heart failure caused by specific heart muscle diseases such as infiltrative cardiomyopathy, active myocarditis (heart muscle inflammation), constrictive pericarditis (thickened heart lining), cardiac tamponade (fluid around the heart), genetic hypertrophic cardiomyopathy (thickened heart muscle), or arrhythmogenic right ventricular cardiomyopathy/dysplasia (a disease of the right ventricle).
Elecoglipron is an experimental oral tablet being tested in this study. Participants take it by mouth to see if it can lower the chance of death from heart problems or the need for urgent hospital visits for heart failure. The drug is still under investigation, so its safety and how well it works are being carefully measured during the trial.
Forxiga (dapagliflozin) is a background medication that participants may already be using. It is an oral tablet that belongs to a class of drugs called SGLT2 inhibitors. Forxiga helps lower blood sugar levels and is also known to support heart health, especially in people with heart failure. In this trial, it is continued as part of the usual care while the new drug is being studied.
Heart failure with preserved ejection fraction – This condition occurs when the heart’s pumping strength is normal but the chambers are stiff, making it difficult for blood to fill the heart. The reduced filling leads to symptoms such as shortness of breath, fatigue, and swelling in the legs. Over time, the stiffness can increase, causing the symptoms to become more frequent and limiting everyday activities. The disease progresses gradually as the heart’s ability to relax and accept blood worsens.
Heart failure with mildly reduced ejection fraction – In this form, the heart’s pumping ability is slightly lower than normal, falling between fully normal and clearly reduced function. Patients experience similar signs of fluid buildup, like breathlessness and leg swelling. The condition may advance as the heart’s contractile strength continues to decline, leading to more pronounced symptoms. Without intervention, the disease can evolve toward more severe heart failure as the heart’s performance worsens.
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