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Antisense Oligonucleotide

Olezarsen for High Triglycerides

Verified Trial
Phase 3
Recruiting
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 month 6 and month 12
Awards & highlights

Study Summary

This trial will compare the effects of olezarsen versus placebo on fasting triglyceride levels.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and month 12 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 25 and 27) Compared to Placebo
Secondary outcome measures
Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
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
+9 more

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
~330

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
14,892 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,232 Patients Enrolled for Hypertriglyceridemia

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05552326 — Phase 3
Hypertriglyceridemia Research Study Groups: Placebo, Olezarsen
Hypertriglyceridemia Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05552326 — Phase 3
Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552326 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different research centers are conducting this trial?

"The trial is being conducted at 7 sites which are situated in North Miami Beach, Louisville and Lexington as well other cities. If you're looking to enroll it would be best to select the closest location to reduce travel time commitments."

Answered by AI

How large is the total patient pool for this research?

"In order for this trial to move forward, 390 patients that fit the inclusion criteria are needed. Currently, those meeting the requirements can sign up to participate at Harmony Clinical Research, Inc in North Miami Beach, Florida and Louisville Metabolic and Atherosclerosis Research Center (L-MARC) in Louisville, Kentucky."

Answered by AI

What are some of the more severe side effects associated with Olezarsen?

"Given that this is a Phase 3 trial with evidence of efficacy and rounds of safety data, our team has rated the safety of Olezarsen as a 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
FMC Science
Main Street Physicians Care Waterway
Other
Clinical Trials of America, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
2022. "A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05552326.
~154 spots leftby Jun 2025
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