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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.
Must not have
Estimated GFR < 30 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 and 12
Awards & highlights
Pivotal Trial
Summary
This trial tests olezarsen, a new drug, to see if it can lower blood fat levels in people with high triglycerides. The goal is to help those who may not respond to usual treatments by reducing their blood fat and preventing health problems. Olezarsen is a new drug being tested to address the unmet need for effective triglyceride-lowering treatments, as current medications often fail to achieve normal triglyceride levels.
Who is the study for?
This trial is for people with severe hypertriglyceridemia, a condition with very high levels of triglycerides in the blood. Participants must be on stable lipid-lowering therapy according to local guidelines for at least 4 weeks before joining. They can't join if they have severely impaired kidney function, uncontrolled diabetes (HbA1c ≥ 9.5%), or significantly elevated liver enzymes.
What is being tested?
The study tests Olezarsen's effectiveness against a placebo in reducing fasting triglyceride levels from the start of the trial. Patients will randomly receive either Olezarsen or a placebo to compare changes in their triglyceride levels.
What are the potential side effects?
Possible side effects of Olezarsen may include reactions at the injection site, fatigue, headache, and potential impacts on liver function which will be closely monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting triglycerides are 500 mg/dL or higher.
Select...
I have been on stable cholesterol-lowering medication for at least 4 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is severely reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo
Secondary study objectives
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 from Week 1 through Week 49.
Group II: PlaceboPlacebo Group1 Intervention
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olezarsen
2022
Completed Phase 3
~1810
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for hypertriglyceridemia include fibrates, omega-3 fatty acids, niacin, and statins. Fibrates activate peroxisome proliferator-activated receptors (PPARs) to increase the oxidation of fatty acids and reduce triglyceride levels.
Omega-3 fatty acids reduce hepatic triglyceride synthesis. Niacin inhibits the release of free fatty acids from adipose tissue, decreasing hepatic triglyceride production.
Statins primarily lower LDL cholesterol but also have modest triglyceride-lowering effects. Olezarsen, an antisense oligonucleotide, reduces the production of ApoC-III, a protein that inhibits lipoprotein lipase, thereby enhancing the breakdown of triglycerides.
These mechanisms are crucial for hypertriglyceridemia patients as they help lower triglyceride levels, reducing the risk of pancreatitis and cardiovascular diseases.
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Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
148 Previous Clinical Trials
14,969 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,248 Patients Enrolled for Hypertriglyceridemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My fasting triglycerides are 500 mg/dL or higher.I have been on stable cholesterol medication for at least 4 weeks.I have been on stable cholesterol-lowering medication for at least 4 weeks.My kidney function is severely reduced.I'm sorry, but "Key" is not a screening criterion. Can you please provide more context or clarify your request?
Research Study Groups:
This trial has the following groups:- Group 1: Olezarsen
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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