Elecoglipron Compared With Placebo in Adults With Certain Types of Heart Failure

Trial details

Who runs it

AstraZeneca

Trial code

NCT07761117EU 2026-526304-79-00

Record updated

28 September 2026

Original description

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.Read full original descriptionShow less

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)

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.

Inclusion: 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: 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; 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; 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; Diabetes exclusions:; History of type 1 diabetes; Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia; History of acute or chronic pancreatitis; History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening; HbA1c ≥10% at screening; On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening; BMI <25 kg/m² at screening; Renal exclusions:; Cardiovascular exclusions:; GI exclusions:; Endocrine exclusions:.

ClinicalTrials.gov NCT07761117 · EU CTIS 2026-526304-79-00