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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258907
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : November 2, 2016
BioInvent International AB
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: MLDL1278A Drug: placebo Drug: statin, stable dose Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: MLDL1278A
Single intravenous dose
Drug: statin, stable dose
Repeating oral dose
Experimental: B Drug: MLDL1278A
Repeating intravenous dose
Drug: statin, stable dose
Repeating oral dose
Placebo Comparator: C Drug: placebo
Repeating intravenous dose
Drug: statin, stable dose
Repeating oral dose

Primary Outcome Measures :
  1. Change in TBR as measured by FDG-PET/CT [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A [ Time Frame: Throughout study or until early discontinuation ]
  2. Effects of MLDL1278A on inflammatory and metabolic biomarkers [ Time Frame: Throughout study or until early discontinuation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Evidence of qualifying vessel (carotid or aortic) plaque inflammation
  • Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
  • Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
  • For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study

Exclusion Criteria:

  • Occurrence of a cardiovascular event < 6 months prior to screening
  • Pregnant, planning to become pregnant during the study, or breastfeeding
  • Clinically significant abnormal laboratory values or abnormal ECG or vital signs
  • History of anaphylactic reactions
  • Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started < 3 months prior to study entry
  • Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
  • Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
  • Impaired renal function
  • History of malignancy within 2 years prior to screening
  • Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
  • Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
  • Exposure to substantial radiation within 12 months prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258907

  Hide Study Locations
United States, California
Torrance, California, United States, 90502
United States, Colorado
Colorado Springs, Colorado, United States, 80904
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32605
Jacksonville, Florida, United States, 32216
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Newington, New Hampshire, United States, 03801
United States, New York
New York, New York, United States, 10001
New York, New York, United States, 10029
North Massapequa, New York, United States, 11758
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
United States, Oregon
Portland, Oregon, United States, 97225-3411
Portland, Oregon, United States, 97239
United States, Texas
Houston, Texas, United States, 77002
Houston, Texas, United States, 77030
Canada, Ontario
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Genentech, Inc.
BioInvent International AB
Study Director: Joshua Lehrer-Graiwer, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT01258907     History of Changes
Other Study ID Numbers: LDL4758g
GC01314 ( Other Identifier: Hoffmann-La Roche )
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs