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

Trial Information
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
Summary

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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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.

Where is this trial taking place?
United States
California
Velocity Clinical Research
Recruiting
Chula Vista
Diabetes/Lipid Management & Research Center
Recruiting
Huntington Beach
America Clinical Trials
Recruiting
Tarzana
Florida
Excel Medical Clinical Trials, LLC
Recruiting
Boca Raton
Ocala Cardiovascular Research
Recruiting
Ocala
Bayside Clinical Research
Recruiting
Trinity
Georgia
IACT Health
Recruiting
Columbus
Iowa
West Broadway Clinic
Recruiting
Council Bluffs
Illinois
Affinity Health
Recruiting
Oak Brook
Michigan
Aa Mrc, Llc
Recruiting
Flint
North Carolina
Novant Health Cancer Institute Elizabeth Investigational Drug Services
Recruiting
Charlotte
Cone Medical Center
Recruiting
Greensboro
Ohio
Aventiv Research
Recruiting
Columbus
Summit Research Group, LLC
Recruiting
Munroe Falls
Oregon
Velocity Clinical Research
Recruiting
Medford
South Dakota
Health Concepts
Recruiting
Rapid City
Texas
Velocity Clinical Research
Recruiting
Cedar Park
University of Texas Southwestern
Recruiting
Dallas
Baylor College of Medicine
Recruiting
Houston
Utah
Velocity Clinical
Recruiting
West Jordan
Virginia
Manassas Clinical Research Center
Recruiting
Manassas
York Clinical Research LLC
Recruiting
Norfolk
Other Locations
Canada
Ecogene-21
Recruiting
Chicoutimi
Clinique des Maladies Lipidiques de Quebec Inc.
Recruiting
Québec
Canadian Phase Onward Inc
Recruiting
Toronto
Spain
Hospital Universitario
Recruiting
Madrid
Who do I contact about this trial?
Primary
Ionis Pharmaceuticals
ionisNCT05079919study@clinicaltrialmedia.com
(844) 980-5110
When is this trial taking place?
Start Date: October 25, 2021
Estimated Completion Date: July 2024
How many participants will be in this trial?
Target number of participants: 540
What treatment is being studied in this trial?
Experimental: Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Placebo Comparator: Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.

This content was sourced from clinicaltrials.gov

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