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)

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