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A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

Clinical Trial Summary

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

Clinical Trial Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in up to approximately 390 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 78 weeks, which includes an up to 12-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. The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552326
Study type Interventional
Source Ionis Pharmaceuticals, Inc.
Contact Ionis Pharmaceuticals
Phone 844-366-0213
Email ionisSHTG2study@clinicaltrialmedia.com
Status Recruiting
Phase Phase 3
Start date August 31, 2022
Completion date July 2025
View Details
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