A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

  • End date
    Feb 22, 2025
  • participants needed
  • sponsor
    Ionis Pharmaceuticals, Inc.
Updated on 22 October 2022
Ionis Pharmaceuticals
Primary Contact
Bayside Clinical Research (0.0 mi away) Contact
+63 other location


The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.


This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 74 weeks, which includes an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Condition Severe Hypertriglyceridemia
Treatment Placebo, ISIS 678354, Olezarsen
Clinical Study IdentifierNCT05079919
SponsorIonis Pharmaceuticals, Inc.
Last Modified on22 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
Estimated GFR < 30 mL/min/1.73 m^2
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note