drugset / Trial / NCT05881382

Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction

NCT05881382

Phase 3 Unknown 4100 enrolled Recardio, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.

Timeline

Start
2023-09
Primary completion
2025-09
Completion
2025-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dutogliptin Small molecule 60 mg Subcutaneous
Comparator filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous