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Olezarsen for High Triglycerides

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
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 and 12
Awards & highlights

Study Summary

This trial is testing whether olezarsen can decrease triglycerides more than a placebo.

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.Check my eligibility
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.See study design
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 below
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My fasting triglycerides are 500 mg/dL or higher.
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I have been on stable cholesterol-lowering medication for at least 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and 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
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 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 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
14,742 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,082 Patients Enrolled for Hypertriglyceridemia

Media Library

ISIS 678354 Clinical Trial Eligibility Overview. Trial Name: NCT05079919 — Phase 3
Hypertriglyceridemia Research Study Groups: Olezarsen, Placebo
Hypertriglyceridemia Clinical Trial 2023: ISIS 678354 Highlights & Side Effects. Trial Name: NCT05079919 — Phase 3
ISIS 678354 2023 Treatment Timeline for Medical Study. Trial Name: NCT05079919 — Phase 3

Frequently Asked Questions

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

Are we still enrolling individuals for this particular clinical research project?

"That is correct. According to the latest information published on clinicaltrials.gov, this study is looking for 540 patients from 36 different centres. The trial was first posted on October 25th, 2021 and was last updated on November 3rd, 2022."

Answered by AI

Does ISIS 678354 have FDA approval for use?

"ISIS 678354 has been deemed safe by our team at Power. We give it a 3 out of 3 because this is a Phase 3 trial, which indicates that not only is there some data supporting efficacy, but multiple rounds of data supporting safety as well."

Answered by AI

Is this a large-scale trial in the US?

"There are multiple enrolling sites for this clinical trial, including West virginia University Heart and Vascular Institute in Morgantown, Northwell Health in Great Neck, Continental Clinical Solutions in Towson. Including these locations, there are a total of 36 enrolling patients."

Answered by AI

How many individuals are being asked to participate in this research project?

"540 patients that match the clinical trial's inclusion criteria are required in order for the study sponsor, Ionis Pharmaceuticals, Inc., to move forward with execution. The trial will be conducted at West virginia University Heart and Vascular Institute in Morgantown, West Virginia and Northwell Health in Great Neck, New york among other locations."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Velocity Clinical Research
Novant Health Cancer Institute Elizabeth Investigational Drug Services
Medicus Alliance Clinical Research
Recent research and studies
clinicaltrials.govStudy
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
2021. "A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05079919.
~77 spots leftby Oct 2024
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