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Completed Phase 3 Interventional Results available

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

ClinicalTrials.gov ID: NCT04568434

Public ClinicalTrials.gov record NCT04568434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 11:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04568434
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
66 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 18, 2020 (Actual)
Primary completion
Jul 14, 2023 (Actual)
Completion
Oct 17, 2023 (Actual)
Last update posted
Mar 6, 2025

2020 – 2023

United States locations

U.S. sites
17
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Diabetes/Lipid Management & Research Center Huntington Beach California 92648 —
University of California, San Francisco (UCSF) - Medical Center San Francisco California 94143 —
Excel Medical Clinical Trials, LLC Boca Raton Florida 33434 —
NorthShore University Health System Evanston Illinois 60201 —
Advocate Health and Hospitals Corporation - Lutheran General Hospital Park Ridge Illinois 60068 —
Ascension St. Vincent Cardiovascular Research Institute Indianapolis Indiana 46290 —
University of Kansas Medical Center (KUMC) Kansas City Kansas 66160 —
University of Michigan- Endocrinology & Metabolism Ann Arbor Michigan 48105 —
New York University (NYU) Langone Medical Center New York New York 10016 —
Columbia University Medical Center New York New York 10032 —
Moses H. Cone Memorial Hospital Greensboro North Carolina 27401 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Vanderbilt University Nashville Tennessee 37232 —
University of Texas Southwestern Dallas Texas 75390 —
Baylor College of Medicine Houston Texas 77030 —
York Clinical Research LLC Norfolk Virginia 23510 —
West Virginia University Heart and Vascular Institute Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04568434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 6, 2025 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04568434 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →