Olezarsen for Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease Management
This study aims to evaluate the effectiveness of Olezarsen in reducing fasting triglycerides by week 25, compared to a placebo, in individuals with hypertriglyceridemia and atherosclerotic cardiovascular disease.
Olezarsen
+ Placebo
Arterial Occlusive Diseases+8
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: November 21, 2022
Actual date on which the first participant was enrolled.This study is about a drug called Olezarsen (ISIS 678354), which is being tested in people with high triglyceride levels and atherosclerotic cardiovascular disease. Atherosclerotic cardiovascular disease is a condition where plaque builds up inside the arteries, which can lead to heart attacks or strokes. The study aims to enroll around 1475 participants. The goal of this research is to understand if Olezarsen can help manage high triglyceride levels, a type of fat found in the blood, and potentially slow down the progression of atherosclerotic cardiovascular disease. During the study, participants will receive either Olezarsen or a placebo (a substance that has no therapeutic effect) once every 4 weeks for about a year. The study is divided into three parts: a screening period, a treatment period, and a follow-up period. The main outcome of interest is the change in fasting triglyceride levels from the start of the study to week 25. Additionally, a sub-study using coronary computed tomographic angiography (CTA), a type of imaging test, will be conducted to see if lowering triglyceride levels through Olezarsen can slow down the progression of plaque buildup in the coronary arteries.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1478 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 168 locations
Alabama Clinical Therapeutics, LLC Alabaster
Birmingham, United StatesOpen Alabama Clinical Therapeutics, LLC Alabaster in Google MapsHeart Center Research PC
Huntsville, United StatesCardiovascular Research Foundation of Southern California
Beverly Hills, United StatesWestside Medical Associates of Los Angeles
Beverly Hills, United States