Testing Maridebart cafraglutide against a placebo for heart failure with preserved ejection fraction

Exclusion

• −Acute or chronic hepatitis.
• −HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
• −Hospitalized with acute decompensated HF at the time of or during the screening periodScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
• −For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
• −HbA1c \> 10.0% (86 mmol/mol) at screening
• −Uncontrolled diabetes requiring immediate therapy
• −History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
• −History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
• −SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \> 160 mmHg during the screening period (including day 1 prior to randomization).
• −History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
• −Any personal lifetime history of, or family history(first-degree relative\[s\]) of medullary thyroid carcinoma or MEN-2.
• −eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
• −Calcitonin ≥ 50 ng/L (pg/mL) at screening.
• −Any of the following psychiatric history:
• −History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
• −Lifetime history of suicide attempt
• −History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
• −History of any other condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may preclude the participant from following the protocolProtocolThe detailed plan a study must follow.Read more → and completing the trial.
• −Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.
• −History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.