Olezarsen for Cardiovascular Disease
Recruiting at27 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Ionis Pharmaceuticals, Inc.
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing olezarsen, a medication aimed at lowering blood fats, in people with high triglycerides who are at risk for heart disease. The medication works by reducing proteins and fats in the blood to help lower cholesterol and triglyceride levels.
Research Team
Eligibility Criteria
Inclusion Criteria
Participants must be willing to comply with diet and lifestyle recommendations as able
Aged ≥ 18 years at the time of informed consent
You have very high levels of triglycerides in your blood when fasting.
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Exclusion Criteria
You have been diagnosed with diabetes within the last 12 weeks.
Your HbA1c level is higher than 9.5% at the screening.
You have changed your basal insulin dose by more than 20% in the 3 months before the screening.
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Treatment Details
Interventions
- Olezarsen (Antisense Oligonucleotide)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlezarsenExperimental Treatment1 Intervention
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ionis Pharmaceuticals, Inc.
Lead Sponsor
Trials
151
Recruited
27,800+
Dr. Brett P. Monia
Ionis Pharmaceuticals, Inc.
Chief Executive Officer since 2020
PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College
Dr. Eric Bastings
Ionis Pharmaceuticals, Inc.
Chief Medical Officer
MD