A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

To be considered for this study, you would need to meet certain health requirements. For example, your heart's pumping ability, measured as 'left ventricular ejection fraction' (LVEF), would need to be above 40% in the last year. You also need to have been diagnosed with heart failure and experiencing symptoms that limit your daily activities, as described by your doctor, falling into a range from New York Heart Association (NYHA) Class II to IV.

There are also some reasons why you might not be able to join. For instance, if your Body Mass Index (BMI) is too low (under 25 kg/m²), or if you have certain types of diabetes, such as Type 1, or if your blood sugar levels (HbA1c) are very high (10% or more). People with a history of serious low blood sugar episodes, specific kidney problems, or who need kidney dialysis, would also not be able to take part.

Additionally, if you've recently had major heart surgery or certain heart procedures in the last three months, or if your heart failure is caused by very specific, rare conditions, you wouldn't be eligible. Certain stomach or bowel conditions, or a history of pancreatitis, might also prevent participation. Finally, if you or your family have a history of a particular type of thyroid cancer called medullary thyroid carcinoma, or a related genetic condition, you would not be able to join.

If you decide to take part in this study, it would involve several steps over a period of time. You would have regular visits to the study clinic where the research team would monitor your health closely. These visits would include check-ups, physical examinations, and blood tests to see how you are responding to the medication and to ensure your safety.

You would be given either the study medicine, Elecoglipron, or the placebo (dummy medicine) to take regularly, in addition to your current heart failure medications, including dapagliflozin. You would be asked to keep a record of any symptoms or side effects you experience. The full duration of your participation would depend on the study design, but generally, these types of Phase 3 studies can last for a year or more, including follow-up appointments after you stop taking the study medicine.