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

RecruitingPhase 3Ages 18 Years - anyAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening. * Structural heart disease evidence. * HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening. Exclusion Criteria: * BMI \<25 kg/mยฒ at screening. * Diabetes exclusions: * History of type 1 diabetes. * HbA1c โ‰ฅ10% at screening. * Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema. * more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition. * Renal exclusions: * On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening * Cardiovascular exclusions: * Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization. * Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia. * GI exclusions: * Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery. * History of acute or chronic pancreatitis. * Endocrine exclusions: * History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin โ‰ฅ35 ng/L at screening.
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What it tests

  • Elecoglipron
  • Placebo
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Where

679 sites
Research Site
Fairhope, United States
Research Site
Anchorage, United States
Research Site
Gilbert, United States
Research Site
Sun City, United States
Research Site
Beverly Hills, United States
Research Site
Huntington Beach, United States
Research Site
Huntington Park, United States
Research Site
Loma Linda, United States

โ€ฆand 671 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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