PHASE 3 PIVOTAL STUDY IN AMI (HEAL-AMI)
HEAL-MI is a global multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that evaluates safety and efficacy of Dutogliptin in co-administration with Filgrastim in Early Recovery Post-Myocardial Infarction.
Status of Study
The study design was already approved by FDA and EMA in 2022, the study is in preparation and patient enrollment in global clinical sites is intended starting in 2023.
Study Design
Based on the completed and promising Phase 2 study results, HEAL-MI will evaluate the safety and efficacy of dutogliptin administered sc in co-administration with filgrastim in adult patients undergoing PCI. In order to observe primary outcome events in patients in this event-driven trial, patients will be randomized in a 1:1 ration to self-administer SC injections of dutogliptin for 14 days in co-administration with filgrastim for 5 days or matching dutogliptin and filgrastim placebo accordingly. heart. The study was seeking primarily to determine safety and the capacity to improve heart function using cardiac MRI for evaluation.
The study is designed as a double-blind, randomized, placebo-controlled trial (Phase 3).
Patient Population
Patients to be enrolled in this study are having an acute myocardial infarction (STEMI) verified by 12-leas electrocardiogram (ECG) and have received local standard of care procedures including (PCI). Treatment will be initiated after completion of the PCI procedure, but not later than 12 hours thereafter.