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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: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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 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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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
Study Completion Date: November 2012
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258907

  Show 24 Study Locations
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: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
BI-204

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

ClinicalTrials.gov processed this record on June 13, 2013