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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)

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01258907
Collaborator
BioInvent International AB (Industry)
147
Enrollment
24
Locations
3
Arms
6.1
Patients Per Site

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Mar 1, 2010
Actual Primary Completion Date :
Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in TBR as measured by FDG-PET/CT [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 [Throughout study or until early discontinuation]

  2. Effects of MLDL1278A on inflammatory and metabolic biomarkers [Throughout study or until early discontinuation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 80 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Torrance California United States 90502
2 Colorado Springs Colorado United States 80904
3 Washington District of Columbia United States 20010
4 Gainesville Florida United States 32605
5 Jacksonville Florida United States 32216
6 Indianapolis Indiana United States 46260
7 Boston Massachusetts United States 02114
8 Haverhill Massachusetts United States 01830
9 Royal Oak Michigan United States 48073
10 Minneapolis Minnesota United States 55455
11 Saint Paul Minnesota United States 55102
12 Kansas City Missouri United States 64111
13 Newington New Hampshire United States 03801
14 New York New York United States 10001
15 New York New York United States 10029
16 North Massapequa New York United States 11758
17 Cincinnati Ohio United States 45219
18 Cincinnati Ohio United States 45227
19 Portland Oregon United States 97225-3411
20 Portland Oregon United States 97239
21 Houston Texas United States 77002
22 Houston Texas United States 77030
23 Ottawa Ontario Canada K1Y 4W7
24 Montreal Quebec Canada H1T 1C8

Sponsors and Collaborators

  • Genentech, Inc.
  • BioInvent International AB

Investigators

  • Study Director: Joshua Lehrer-Graiwer, M.D., Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01258907
Other Study ID Numbers:
  • LDL4758g
  • GC01314
First Posted:
Dec 13, 2010
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Genentech, Inc.
BI-204
Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 2, 2016