What side effects are associated with this type of intervention?

Common treatments for Chylomicronemia Syndrome, such as statins and PCSK9 inhibitors, generally have side effects including muscle pain, liver enzyme abnormalities, and injection site reactions. Specifically, for therapies targeting Apolipoprotein C-III like Olezarsen, potential side effects may include injection site reactions, flu-like symptoms, and possible liver enzyme elevations. It is important to monitor these side effects and discuss them with a healthcare provider to ensure safe and effective treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Chylomicronemia Syndrome, primarily focusing on lowering triglycerides. One notable drug is volanesorsen, an antisense oligonucleotide that inhibits the production of Apolipoprotein C-III, thereby reducing triglyceride levels. Other treatments include fibrates, omega-3 fatty acids, and niacin, which also aim to lower triglycerides but through different mechanisms. These therapies are crucial for managing the severe hypertriglyceridemia associated with Chylomicronemia Syndrome.

What other types of research exist?

Promising novel alternatives to Olezarsen for Chylomicronemia Syndrome patients include: 1) Volanesorsen, an antisense oligonucleotide targeting ApoC-III, which has shown efficacy in reducing triglycerides. 2) Evinacumab, a monoclonal antibody against ANGPTL3, which can significantly lower triglycerides and is approved for homozygous familial hypercholesterolemia. 3) Gene therapies targeting LPL (lipoprotein lipase) deficiencies, which are in development and may offer long-term solutions for managing triglyceride levels.

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Antisense Oligonucleotide

Olezarsen for Chylomicronemia Syndrome

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

Study Summary

This trial will study how well olezarsen works in lowering triglyceride levels in adults.

Who is the study for?

This trial is for people who have Familial Chylomicronemia Syndrome (FCS) and have already been treated with Olezarsen in a previous study without any safety concerns. Participants should not have new or worsening conditions that could affect their ability to complete the study.Check my eligibility

What is being tested?

The trial is testing the effectiveness of a drug called Olezarsen on lowering fasting triglycerides, which are fats found in blood, from where they started at the beginning of treatment.See study design

What are the potential side effects?

While specific side effects for Olezarsen aren't listed here, common ones may include reactions at injection sites, liver enzyme changes, and potential interactions with other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline

Secondary outcome measures

Adjudicated Acute Pancreatitis Event Rate During the Treatment Period

Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Participants With ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Treatment With Study Drug in the Index Study

Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Patients with a Prior History of Pancreatitis within 10 Years Prior to Screening in the Index Study

+15 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: OlezarsenExperimental Treatment1 Intervention

Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 153.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olezarsen

2022

Completed Phase 3

~330

Do I qualify?Apply below to find out

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

Chylomicronemia Syndrome is primarily treated by targeting elevated triglyceride levels, which are a hallmark of the condition. One of the most promising treatments is the inhibition of Apolipoprotein C-III (ApoC-III), as seen with Olezarsen. ApoC-III is a protein that inhibits the breakdown of triglycerides; by reducing its activity, triglyceride levels in the blood can be significantly lowered. This is crucial for patients with Chylomicronemia Syndrome because high triglyceride levels can lead to severe complications such as pancreatitis. Other treatments may include dietary modifications and medications like fibrates and omega-3 fatty acids, which also help reduce triglyceride levels through different mechanisms, such as enhancing triglyceride clearance or reducing triglyceride synthesis. Lowering triglycerides is essential for managing symptoms and preventing complications in these patients.

Clinical perspective: have the results of recent clinical trials of lipid-lowering therapies influenced the way we should practice? A Latin American perspective of current issues in clinical lipidology.

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

147 Previous Clinical Trials

15,388 Total Patients Enrolled

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05130450 — Phase 3

Chylomicronemia Syndrome Research Study Groups: Olezarsen

Chylomicronemia Syndrome Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05130450 — Phase 3

Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130450 — Phase 3

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