Clinical Trials Logo
  1. Home
  2. Severe Hypertriglyceridemia
  3. NCT05681351

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

Severe Hypertriglyceridemia Clinical Trial

Official title:
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Clinical Trial Description

This is a multi-center, open-label study of up to 700 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period. The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05681351
Study type Interventional
Source Ionis Pharmaceuticals, Inc.
Contact Ionis Pharmaceuticals, Inc.
Phone (844) 274-0709
Email ionisSHTG3study@clinicaltrialmedia.com
Status Recruiting
Phase Phase 3
Start date December 13, 2022
Completion date September 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT01208961 - Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation Phase 2
Completed NCT04541186 - Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia Phase 2
Active, not recruiting NCT05079919 - A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia Phase 3
Completed NCT02189252 - An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis Phase 1
Active, not recruiting NCT01229566 - Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia Phase 3
Completed NCT03001817 - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function Phase 3
Completed NCT03011450 - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment Phase 3
Completed NCT05355402 - 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 Phase 2
Completed NCT04720534 - Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia Phase 2
Recruiting NCT06347003 - Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia Phase 3
Recruiting NCT06347016 - Study of Plozasiran in Adults With Severe Hypertriglyceridemia Phase 3
Withdrawn NCT04662528 - Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL Phase 3
Recruiting NCT05852431 - To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia Phase 3
Completed NCT01242527 - Epanova® for Lowering Very High Triglycerides Phase 2/Phase 3
Completed NCT02944383 - A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia Phase 2
Recruiting NCT05552326 - A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia Phase 3
Withdrawn NCT01997268 - The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL) Phase 3