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Antisense Oligonucleotide

Olezarsen for Cardiovascular Disease

Phase 2
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 baseline, months 6 and 12
Awards & highlights

Study Summary

This trial is looking at the effect of a new drug, olezarsen, on triglyceride levels compared to placebo. Another objective is to see the effect of the drug on different types of cholesterol.

Eligible Conditions
  • Severe Hypertriglyceridemia
  • High Triglycerides
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 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 at Month 6 (average of Weeks 25 and 27) in Fasting Triglycerides (TG)
Secondary outcome measures
Adjudicated acute pancreatitis event rate during the Treatment Period compared to placebo in patients 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.
Percent Change From Baseline at Month 12 in Fasting TG
+13 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 for up to 49 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
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
15,128 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
3,468 Patients Enrolled for Hypertriglyceridemia

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05355402 — Phase 2
Hypertriglyceridemia Research Study Groups: Olezarsen, Placebo
Hypertriglyceridemia Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05355402 — Phase 2
Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355402 — Phase 2

Frequently Asked Questions

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

Could you provide a tally of how many research facilities are handling this project?

"To limit the amount of travel required, patients should enroll at the clinical trial site closest to them. Currently, there are 28 sites active across North America in locations such as Sarnia, Tarzana, New Port Richey and other cities."

Answered by AI

Does Olezarsen have any serious adverse effects for patients?

"While there is some data supporting the safety of Olezarsen, it received a score of 2 because this is only Phase 2. This lack of evidence surrounding efficacy."

Answered by AI

How can people sign up to participate in this research?

"No, this particular trial is not currently looking for patients according to the information available on clinicaltrials.gov. This research was first posted on May 9th, 2022 and last updated on October 26th, 2022. However, there are 553 other trials that are still recruiting right now."

Answered by AI

Who else is applying?

What site did they apply to?
Affinity Health Corp.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have been on 3 different medications and I am still not in the “normal “ range.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
2022. "A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05355402.
~53 spots leftby Apr 2025
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