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Antisense Oligonucleotide
Olezarsen for Cardiovascular Disease
Phase 2
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
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.
Eligible Conditions
- Severe Hypertriglyceridemia
- Hypertriglyceridemia
- High Triglycerides
- Cardiovascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olezarsen
2022
Completed Phase 3
~1810
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Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
148 Previous Clinical Trials
15,355 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,634 Patients Enrolled for Hypertriglyceridemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.If you have type 1 diabetes, you had a serious problem called diabetic ketoacidosis or had very low blood sugar three or more times in the last 6 months.You had a heart attack or stroke in the last 6 months before the screening.You had a major surgery, peripheral revascularization, or non-urgent heart procedure in the last 3 months, or you are planning to have a major surgery or procedure during the study.You have had pancreatitis in the past 4 weeks.You have very high levels of triglycerides in your blood when fasting.You have high levels of triglycerides in your blood and either have been diagnosed with atherosclerotic cardiovascular disease or have an increased risk for it.
Research Study Groups:
This trial has the following groups:- Group 1: Olezarsen
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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