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)

AstraZeneca

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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/m² at screening. * Diabetes exclusions: * History of type 1 diabetes. * HbA1c ≥10% 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 una…

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)

Summary

Eligibility

Interventions

Locations (672)