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COMPLETED
NCT05355402
PHASE2

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

Sponsor: Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).

Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2b Study of ISIS 678354 in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2022-05-09

Completion Date

2023-12-21

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

DRUG

Olezarsen

SC injection.

DRUG

Placebo

SC injection.

Locations (24)

Clinical Trials Research

Lincoln, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, United States

De La Cruz Research Center

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Research Physicians Network Alliance

Winter Park, Florida, United States

IACT Health

Columbus, Georgia, United States

Evanston Premier Healthcare Research

Evanston, Illinois, United States

Clinical Investigation Specialist

Gurnee, Illinois, United States

West Broadway Clinic

Council Bluffs, Iowa, United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, United States

Aa Mrc, Llc

Flint, Michigan, United States

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Palm Research Center, Inc.

Las Vegas, Nevada, United States

Green and Seidner Family Practice Associates

Lansdale, Pennsylvania, United States

Main Street Physicians Care Waterway

Little River, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

York Clinical Research LLC

Norfolk, Virginia, United States

Bluewater Clinical Research Group Inc

Sarnia, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

Clinique des Maladies Lipidiques de Quebec Inc.

Québec, Canada