A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key 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.

Key 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/15/23. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Regis Fernandes, M.D.

Closed for enrollment

Contact information:

Shan Luc-Kenney R.N.

(480) 301-9769

Luc-Kenney.Shan@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20549317

Mayo Clinic Footer