A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

October 17, 2025 updated by: Ionis Pharmaceuticals, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro
      • Buenos Aires, Argentina, C1425AGC
        • Centro Médico Dra. Laura Maffei
      • Buenos Aires, Argentina, C1430
        • Glenny Corp SA
      • Buenos Aires, Argentina, C1061AAG
        • Ciprec - Centro de Investigacion y Prevencion Cardiovascular
      • Corrientes, Argentina, W3400CDS
        • Instituto de Cardiología Corrientes
      • Córdoba, Argentina, X5003DCE
        • Instituto Médico DAMIC
      • San Luis, Argentina, D5700
        • Centro Medico San Luis
      • Villa María, Argentina, X5900JKA
        • Clinica FUSAVIM Privada
  • Belgium
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Hasselt, Belgium, 3500
        • Virga Jessa Hospital
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Brazil
      • Belo Horizonte, Brazil, 30220-140
        • NUPEC - Nucleo de Pesquisa Clinica
      • Curitiba, Brazil, 80730-150
        • Nucleo de Pesquisa Clinica
      • Fortaleza, Brazil, 60430-270
        • Hospital Universitário Walter Cantídio - UFC
      • Porto Alegre, Brazil, 90035-903
        • Núcleo de Pesquisa em Cirurgia Vascular
      • Rio de Janeiro, Brazil, 20241-180
        • IBPClin Pesquisa Clinica
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 05403-000
        • Instituto do Coração - HCFMUSP
      • São Paulo, Brazil, 13092-133
        • i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores
      • São Paulo, Brazil, 05403-900
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - FMUSP
  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
        • Medical Center Diamedical EOOD
      • Haskovo, Bulgaria, 6304
        • MHAT Haskovo AD
      • Pazardzhik, Bulgaria, 4400
        • MHAT Pazardzhik AD
      • Plovdiv, Bulgaria, 4000
        • University Multiprofile Hospital for Active Treatment Pulmed OOD
      • Plovdiv, Bulgaria, 4000
        • UMHAT - Kaspela EOOD
      • Rousse, Bulgaria, 7002
        • UMHAT Kanev AD
      • Sliven, Bulgaria, 8800
        • MHAT Sliven to MMA Sofia
      • Smolyan, Bulgaria, 4700
        • Medical center Smolyan clinical research OOD
      • Sofia, Bulgaria, 1784
        • Medical Centre Synexus Sofia EOOD
      • Sofia, Bulgaria, 1000
        • Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
      • Sofia, Bulgaria, 1527
        • Medico Dental Center ISUL Tsaritsa Yoanna EOOD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital
      • Stara Zagora, Bulgaria, 6000
        • Medical Center Zara - Med
      • Varna, Bulgaria, 9000
        • DCC Equita
      • Varna, Bulgaria, 9000
        • Specialized Hospital for Active Treatment of Cardiology
      • Veliko Tarnovo, Bulgaria, 5006
        • Medical Centre "Nevromedics" EOOD
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • NL Health Services
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Ltd.
      • Cambridge, Ontario, Canada, N3H 4L5
        • Joanne F. Liutkus Medicine Professional Corporation
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group
      • Toronto, Ontario, Canada, M5G2C4
        • Toronto General Hospital
    • Quebec
      • Saint-Jérôme, Quebec, Canada, J7Z 2V4
        • Unite de Recherche Clinique
  • Czechia
      • Hodonín, Czechia, 695 01
        • CTC Hodonin s.r.o.
      • Louny, Czechia, 440 01
        • KardioBusak s.r.o.
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
      • Prague, Czechia, 198 00
        • Endokrinologie Cerny Most s.r.o.
      • Příbram, Czechia, 267 01
        • Diabetologická a endokrinologická ambulance Milan Kvapil
      • Teplice, Czechia, 415 01
        • AeskuLab k.s
  • France
      • Strasbourg, France, 67098
        • Hôpital de Hautepierre
      • Valenciennes, France, 59300
        • ELSAN - Polyclinique Vauban
      • Vénissieux, France, 69200
        • GHM les Portes du Sud
  • Greece
      • Alexandroupoli, Greece, 68100
        • University General Hospital of Alexandroupoli
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Athens, Greece, 12462
        • University General Hospital Attikon
      • Athens, Greece, 10676
        • AHEPA Building of Evaggelismos
      • Thessaloniki, Greece, 54636
        • AHEPA University General Hospital of Thessaloniki
  • Hungary
      • Baja, Hungary, H-6500
        • Lausmed Kft.
      • Balatonfüred, Hungary, H-8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Budapest, Hungary, H-1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Hungary, H1033
        • Clinexpert Kft.
      • Gyöngyös, Hungary, H-3200
        • Pharma4 Trial Kft.
      • Kaposvár, Hungary, H-7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz Diabetologiai szakrendeles
  • India
      • Bengaluru, India, 560069
        • Sri Jayadeva Institute of Cardiovascular Sciences and Research
      • Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • Jaipur, India, 302017
        • Eternal Hospital
      • Kolkata, India, 700020
        • IPGMER
      • Mangaluru, India, 575003
        • Vinaya Hospital and Research Centre (A Unit of Karnataka Institute of Medical Sciences)
      • Mumbai, India, 400007
        • Bhatia Hospital
      • Mumbai, India, 4000012
        • KEM Hospital
      • Mysore, India, 570015
        • Manipal Hospital Mysore
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Max Super Specialty Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700027
        • B. M. Birla Heart Research Centre A Unit of the Calcutta Medical Research Institute
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
      • Caserta, Italy, 81100
        • AORN S. Anna e S. Sebastiano UOC FARMACIA
      • Cona, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
      • Pavia, Italy, 27100
        • Fondazione I.R.C.C.S. Policlinico "San Matteo" c/o C.U.R.M.
  • Lithuania
      • Kaunas, Lithuania, 49449
        • Saules seimons medicinos centras
      • Kaunas, Lithuania, LT-49387
        • Klinikiniai sprendimai
      • Klaipėda, Lithuania, LT-91131
        • Clinic of Cardiology and Rehabilitation
      • Panevezys, Lithuania, LT-35144
        • Republican Panevezys Hospital
      • Šiauliai, Lithuania, LT-76206
        • Pirmoji Viltis
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
    • Kedah
      • Alor Star, Kedah, Malaysia, 05460
        • Sultanah Bahiyah Hospital
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Pulau Pinang Hospital
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.
      • Chihuahua City, Mexico, 32103
        • Cientia Investigacion Clinica Sc
      • Mexico City, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • Tlanepantla, Mexico, 54055
        • Clinical Research Institute S.C.
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care and Research S.A de C.V.
  • Netherlands
      • Amsterdam, Netherlands, 1081BT
        • Vumc Amsterdam Medical Center
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen Apeldoorn
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf Ziekenhuis
      • Dirksland, Netherlands, 3247BW
        • Het Van Weel Bethesda ziekenhuis
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer ziekenhuis
      • Hoogeveen, Netherlands, 7909 AA
        • Bethesda Diabetes Research Center
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis (CWZ)
  • Poland
      • Gdansk, Poland, 80-214
        • UCK, I Klinika Kardiologii
      • Józefów, Poland, 05-410
        • Biokinetica
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia
      • Lodz, Poland, 91-053
        • Centra Medyczne Medyceusz
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lublin, Poland, 20-078
        • Clinical Best Solutions
      • Poznan, Poland, 60-589
        • Centrum Zdrowia Metabolicznego
      • Warsaw, Poland, 00-710
        • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
      • Warsaw, Poland, 03-291
        • Centrum Medycnze AMED
      • Warsaw, Poland, 04-628
        • Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB
      • Zamość, Poland, 22-400
        • ETG Zamosc / Pro Life Medica Sp. z o.o.
  • Portugal
      • Lisbon, Portugal, 1350-352
        • Hospital CUF Tejo
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga
  • Romania
      • Alba, Romania, 510053
        • Cabinet Medical Individual SC DIANA BARBONTA SRL
      • Baia Mare, Romania, 430123
        • Cardioplus Center SRL
      • Brasov, Romania, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
      • Bucharest, Romania, 10626
        • Centrul Medical Medicover Victoria
      • Piteşti, Romania, 10437
        • S.C. SAL MED S.R.L., Cardiologie
      • Târgu Mureş, Romania, 540124
        • Cardio Med SRL
      • Târgu Mureş, Romania, 540142
        • S.C. Mediab Srl
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Alian s.r.o.
      • Bratislava, Slovakia, 83106
        • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
      • Lučenec, Slovakia, 98401
        • Interna a diabetologicka ambulancia - IN-DIA s.r.o.
      • Rožňava, Slovakia, 04801
        • DIAB sro
      • Svidník, Slovakia, 08901
        • Interna SK, s.r.o.
      • Trebišov, Slovakia, 07501
        • Areteus s.r.o
  • Spain
      • Badalona, Spain, 8916
        • Hospital Germans Trías i Pujol
      • Barcelona, Spain, 8035
        • Hospital Vall d'hebrón
      • Huelva, Spain, 21007
        • Hospital Comarcal Infanta Elena
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Málaga, Spain, 29009
        • Hospital Regional De Malaga
      • Málaga, Spain, 29010
        • Unidad de Ensayos Clinicos
      • Santiago de Compostela, Spain, 15706
        • Hospital Provincial de Conxo
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Sweden
      • Solna, Sweden, SE-171 64
        • Acardo MedSite
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
      • New Taipei City, Taiwan, 251404
        • Mackay Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan City, Taiwan, 704017
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 111045
        • Shin Kong Wu Ho-Su Memorial Hospital
      • Taoyuan District, Taiwan, 33305
        • Chang Gung Medical Foundation - Linkou Branch
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc.
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC Alabaster
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Onyx Clinical Research
    • California
      • Los Angeles, California, United States, 90015
        • NRC Research Institute
    • Florida
      • DeLand, Florida, United States, 32720
        • Accel Research Sites
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Jacksonville, Florida, United States, 32209
        • University of Florida Jacksonville
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research, Inc
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando Phase I-IV
      • Sunrise, Florida, United States, 33325
        • 3Sync Research
      • Tampa, Florida, United States, 33634
        • JSV Clinical Research Study, Inc.
      • Tampa, Florida, United States, 33614
        • R & B Medical Center LLC
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Eatonton, Georgia, United States, 31024
        • Accel Clinical Research
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Newnan, Georgia, United States, 30265
        • Randomize Now
    • Indiana
      • Carmel, Indiana, United States, 46290
        • St. Vincent Medical Group
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (KUMC)
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington, LLC
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40213
        • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America LA, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
      • Baltimore, Maryland, United States, 21229
        • Maryland Cardiovascular Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Flint, Michigan, United States, 48532
        • Onyx Clinical Research
      • Rochester Hills, Michigan, United States, 48307
        • Onyx Clinical Research
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Stern Cardiovascular
    • New York
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • Orchard Park, New York, United States, 14127
        • Orchard Park Family Practice
    • North Carolina
      • Lenoir, North Carolina, United States, 28645
        • Clinical Trials of America, LLC
      • Morehead City, North Carolina, United States, 28557
        • Diabetes and Endocrinology Consultants, P.C.
      • Salisbury, North Carolina, United States, 28144
        • OnSite Clinical Solutions, LLC
    • Ohio
      • Columbus, Ohio, United States, 43203
        • The Ohio State University (OSU)
      • Marion, Ohio, United States, 43302
        • SV Research LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Oklahoma Heart Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Little River, South Carolina, United States, 29566
        • Main Street Physicians Care Waterway
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Clinical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Texas Health Family Care
      • Houston, Texas, United States, 77017
        • Vilo Research Group
      • Houston, Texas, United States, 77040
        • Juno Research
      • Houston, Texas, United States, 77054
        • Juno Research
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research, LLC
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • McAllen, Texas, United States, 78503
        • DCT - McAllen Primary Care, LLC
      • McKinney, Texas, United States, 75071
        • Texas Institute of Cardiology
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research, LLC
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A.
      • Webster, Texas, United States, 77598
        • Tranquil Research
    • Utah
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research
      • Roy, Utah, United States, 84401
        • Ogden Clinic Grandview
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Clinical Investigation Specialists Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
  2. Participants 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.
  3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

  1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome
  4. Estimated GFR < 30 mL/min/1.73 m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Drug: Olezarsen
Olezarsen will be administered by SC injection.
Other Names:
  • ISIS 678354
  • AKCEA-APOCIII-LRx
Placebo Comparator: Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Drug: Placebo
Olezarsen-matching placebo will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Fasting TG Compared to Placebo
Time Frame: Baseline and Month 6
Baseline and Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Percent Change from Baseline in Fasting TG Compared to Placebo
Time Frame: Baseline and Month 12
Baseline and Month 12
Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo
Time Frame: Month 12
Month 12
Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL
Time Frame: Month 12
Month 12
Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo
Time Frame: Baseline through Month 12
Baseline through Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISIS 678354-CS6
  • 2022-501420-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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