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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
BioInvent International AB
Age
35–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
