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Antisense Oligonucleotide
Olezarsen for High Triglycerides
Verified Trial
Phase 3
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
Must not have
Estimated GFR < 30 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new medication called olezarsen to see if it can lower blood fat levels in people with high triglycerides. The goal is to find out if olezarsen can effectively reduce triglycerides and help prevent related health issues. Olezarsen has been shown to significantly reduce apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.
Who is the study for?
This trial is for people with severe hypertriglyceridemia, having fasting triglycerides of 500 mg/dL or higher. Participants should be on a stable lipid-lowering therapy for at least 4 weeks and willing to follow diet and lifestyle advice. Those with certain liver, kidney, or blood sugar conditions are excluded.
What is being tested?
The study tests the effectiveness of Olezarsen in reducing fasting triglyceride levels compared to a placebo. Participants will receive either Olezarsen or a placebo injection and their change in triglyceride levels from the start of the study will be measured.
What are the potential side effects?
While specific side effects for Olezarsen aren't provided here, similar medications can cause reactions at the injection site, liver enzyme changes, potential kidney issues, and may affect blood sugar control.
Eligibility Criteria
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & 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 subcutaneous (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), which increase the oxidation of fatty acids and reduce triglyceride levels.
Omega-3 fatty acids reduce hepatic triglyceride synthesis and increase triglyceride clearance. Niacin inhibits the release of free fatty acids from adipose tissue, reducing hepatic triglyceride production.
Statins primarily lower LDL cholesterol but also have modest triglyceride-lowering effects. Olezarsen, an antisense oligonucleotide targeting ApoC-III, reduces triglyceride levels by inhibiting the production of ApoC-III, a protein that inhibits lipoprotein lipase and hepatic uptake of triglyceride-rich particles.
These mechanisms are crucial for hypertriglyceridemia patients as they help reduce the risk of pancreatitis and cardiovascular disease by lowering elevated triglyceride levels.
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Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
150 Previous Clinical Trials
27,216 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,475 Patients Enrolled for Hypertriglyceridemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on stable cholesterol-lowering medication for at least 4 weeks.My kidney function is severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Olezarsen
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.