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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258907

Enrollment

147

Registered

2010-12-13

Start date

2010-03-31

Completion date

Unknown

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

BI-204

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.

Interventions

DRUGMLDL1278A

Single intravenous dose

DRUGplacebo

Repeating intravenous dose

DRUGstatin, stable dose

Repeating oral dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in TBR as measured by FDG-PET/CT	Baseline to Week 12

Secondary

Measure	Time frame
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
Effects of MLDL1278A on inflammatory and metabolic biomarkers	Throughout study or until early discontinuation

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026