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Clinical Trial Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction

Clinical Trial Description

Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI) with successful revascularization following percutaneous coronary intervention (PCI) and stent implantation.

Primary Objective

• To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo

Secondary Objectives

- To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo as determined by cardiac magnetic resonance imaging (cMRI)

- To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population

- To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset of the study population

Exploratory Objectives

- To examine the effects of dutogliptin in combination with filgrastim on:

- Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels

- Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03486080
Study type Interventional
Source Recardio, Inc.
Status Enrolling by invitation
Phase Phase 2
Start date December 7, 2018
Completion date March 2020

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