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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

BMI <25 kg/m² at screening.

History of type 1 diabetes.

HbA1c ≥10% at screening.

Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.

Trial design

Treatments tested in this trial

  • Elecoglipron
  • Placebo

Treatment groups

6,950 Participants
are divided into 2 treatment groups

Sponsors and collaborators