A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

March 28, 2024 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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in up to approximately 390 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.

The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 3

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 Locations

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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo
Time Frame: Baseline and Month 6
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) Compared to Placebo
Time Frame: Baseline and Month 12
Baseline and Month 12
Percent Change from Baseline in Fasting Very Low-Density Lipoprotein Cholesterol (VLDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Proportion of Participants Who Achieve Fasting TG Less Than (<) 500 milligrams per deciliter (mg/dL) (5.7 millimoles per liter [mmol/L]) at 6 and 12 Months Compared to Placebo
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) at 6 and 12 Months Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Percentage of Participants Achieving Fasting TG < 1000 mg/dL in Participants with Baseline TG ≥ 1000 mg
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
Time Frame: Week 13 through Week 53
Week 13 through Week 53
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo
Time Frame: Week 13 through Week 53
Week 13 through Week 53

Collaborators and Investigators

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

Sponsor

Ionis Pharmaceuticals, Inc.

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)

August 31, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 678354-CS6
  • 2022-501420-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Conditions

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Locations

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