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Antisense Oligonucleotide

Olezarsen for High Triglycerides and Cardiovascular Disease

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
Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter [mmol/L]) and <500 mg/dL (5.65 mmol/L) with either Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or At increased risk for ASCVD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 25 and 53
Awards & highlights

Study Summary

This trial studies the effects of a drug on triglyceride levels for people with high triglycerides and cardiovascular disease.

Who is the study for?
This trial is for adults with high blood fat levels (triglycerides) and heart disease or at risk of it. They must be on stable heart medications for 4 weeks before joining. People with severe liver issues, very poor kidney function, or uncontrolled diabetes can't participate.Check my eligibility
What is being tested?
The study tests Olezarsen's ability to lower fasting triglyceride levels compared to a placebo in patients with high triglycerides and heart disease or those at high risk. It aims to see if Olezarsen is more effective than no treatment.See study design
What are the potential side effects?
Possible side effects of Olezarsen may include reactions at the injection site, changes in liver enzymes, reduced kidney function, low platelet counts, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with heart disease caused by hardened arteries.
Select...
I have high triglycerides and am at risk for heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 25 and 53
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 25 and 53 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 to Week 25 in Fasting Triglycerides (TG) 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
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlezarsenExperimental Treatment1 Intervention
Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection for up to Week 49.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection for up to 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
13,970 Total Patients Enrolled

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05610280 — Phase 3
High Triglycerides Research Study Groups: Placebo, Olezarsen
High Triglycerides Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05610280 — Phase 3
Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610280 — Phase 3

Frequently Asked Questions

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

What is the current scale of participation in this research endeavor?

"Indeed, according to clinicaltrials.gov, this medical trial is actively searching for enrollees and has been since November 21st 2022. As of the most recent update on 11/23/2022, 1312 participants are needed from a single location."

Answered by AI

To what extent is Olezarsen a risk to human health?

"With a score of 3, our team has affirmed that Olezarsen is safe for human consumption as it has been through multiple rounds of clinical testing and efficacy studies."

Answered by AI

Is this research endeavor currently accepting volunteers?

"This clinical trial, which was first advertised on November 21st 2022, is actively seeking patients and has recently been updated. Information regarding this study can be found on the website of clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Clinical Research of South Nevada
Main Street Physicians Care Waterway
Summit Research Group, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Need help to lower my cholesterol.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Summit Research Group, LLC: < 48 hours
  2. Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center: < 48 hours
  3. Affinity Health: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
2022. "A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610280.
All > Atherosclerosis
~486 spots leftby Mar 2025
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