NCT01258907

A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)

A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DRUG	MLDL1278A	Single intravenous dose
DRUG	MLDL1278A	Repeating intravenous dose
DRUG	placebo	Repeating intravenous dose
DRUG	statin, stable dose	Repeating oral dose

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-07-01
• First posted: 2010-12-13
• Last updated: 2016-11-02

Locations

24 sites across 2 countries: United States, Canada