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)

This study has been completed.
Sponsor:
Collaborator:
BioInvent International AB
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01258907
First received: December 10, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Drug: MLDL1278A
Drug: placebo
Drug: statin, stable dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Change in TBR as measured by FDG-PET/CT [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Effects of MLDL1278A on inflammatory and metabolic biomarkers [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: March 2010
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258907

  Hide Study Locations
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
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, Mississippi
Haverhill, Mississippi, United States, 01830
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, 97239
Portland, Oregon, United States, 97225-3411
United States, Texas
Houston, Texas, United States, 77030
Houston, Texas, United States, 77002
Canada, Ontario
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Genentech
BioInvent International AB
Investigators
Study Director: Joshua Lehrer-Graiwer, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01258907     History of Changes
Other Study ID Numbers: LDL4758g, GC01314
Study First Received: December 10, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
BI-204

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014