NCT05881382

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

Phase 3, Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,100 (estimated)
• Sponsor: Recardio, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Dutogliptin + Filgrastim	dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.
DRUG	Placebo	Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-05-31
• Last updated: 2023-06-05

Regulatory

• FDA-regulated drug study