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A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Primary Purpose

Severe Hypertriglyceridemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olezarsen
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia focused on measuring Hypertriglyceridemia, Hyperlipidemias, Metabolic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Research Associates, Inc.Recruiting
  • Alabama Clinical Therapeutics, LLC AlabasterRecruiting
  • Accel Research SitesRecruiting
  • Finlay Medical ResearchRecruiting
  • Meridien ResearchRecruiting
  • Columbus Clinical ServicesRecruiting
  • Harmony Clinical Research, IncRecruiting
  • Combined Research Orlando Phase I-IVRecruiting
  • 3Sync ResearchRecruiting
  • R & B Medical Center LLCRecruiting
  • JSV Clinical Research Study, Inc.Recruiting
  • Metabolic Research InstituteRecruiting
  • Accel Clinical ResearchRecruiting
  • Randomize NowRecruiting
  • St. Vincent Medical GroupRecruiting
  • The Research Group of Lexington, LLCRecruiting
  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)Recruiting
  • Grace Research, LLCRecruiting
  • Clinical Trials of America LA, LLCRecruiting
  • Maryland Cardiovascular SpecialistsRecruiting
  • Orchard Park Family PracticeRecruiting
  • Clinical Trials of America, LLCRecruiting
  • Diabetes and Endocrinology Consultants, P.C.Recruiting
  • The Ohio State University (OSU)Recruiting
  • SV Research LLCRecruiting
  • Oklahoma Heart InstituteRecruiting
  • University of PennsylvaniaRecruiting
  • Medical University of South Carolina (MUSC)Recruiting
  • Main Street Physicians Care WaterwayRecruiting
  • Monument Health Clinical ResearchRecruiting
  • Texas Health Family CareRecruiting
  • Juno ResearchRecruiting
  • Juno ResearchRecruiting
  • Clinical Trial NetworkRecruiting
  • Pioneer Research Solutions, IncRecruiting
  • FMC ScienceRecruiting
  • DCT - McAllen Primary Care, LLCRecruiting
  • McAllen Primary Care, LLCRecruiting
  • Texas Institute of CardiologyRecruiting
  • SMS Clinical Research, LLCRecruiting
  • Southern Endocrinology AssociatesRecruiting
  • Permian Research FoundationRecruiting
  • Diabetes & Glandular Disease Clinic, P.A.Recruiting
  • Tranquil ResearchRecruiting
  • Aspen Clinical ResearchRecruiting
  • Clinical Investigation Specialists Inc.Recruiting
  • MHAT Haskovo ADRecruiting
  • UMHAT - Kaspela EOODRecruiting
  • University Multiprofile Hospital for Active Treatment Pulmed OODRecruiting
  • UMHAT Kanev ADRecruiting
  • MHAT Sliven to MMA SofiaRecruiting
  • Medical Center for Specialized Medical Help in Cardiovascular Diseases OODRecruiting
  • Medical Center Zara - MedRecruiting
  • DCC EquitaRecruiting
  • Specialized Hospital for Active Treatment of CardiologyRecruiting
  • NL Health ServicesRecruiting
  • Aggarwal and Associates Ltd.Recruiting
  • Joanne F. Liutkus Medicine Professional CorporationRecruiting
  • Bluewater Clinical Research GroupRecruiting
  • CTC Hodonin s.r.o.Recruiting
  • KardioBusak s.r.o.Recruiting
  • Endokrinologie Cerny Most s.r.o.Recruiting
  • Diabetologická a endokrinologická ambulance Milan KvapilRecruiting
  • AeskuLab k.sRecruiting
  • Hopital de HautepierreRecruiting
  • ELSAN - Polyclinique VaubanRecruiting
  • GHM les Portes du SudRecruiting
  • Lausmed Kft.Recruiting
  • Obudai Egeszsegugyi CentrumRecruiting
  • Clinexpert Kft.Recruiting
  • Pharma4 Trial Kft.Recruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
  • Saules seimons medicinos centrasRecruiting
  • Clinic of Cardiology and RehabilitationRecruiting
  • Sultanah Bahiyah HospitalRecruiting
  • Hospital TaipingRecruiting
  • Pulau Pinang HospitalRecruiting
  • University Malaya Medical Centre (UMMC)Recruiting
  • Medical Care and Research S.A de C.V.Recruiting
  • Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.Recruiting
  • Cientia Investigacion Clinica ScRecruiting
  • Clinstile, S.A. de C.V.Recruiting
  • Clinical Research Institute S.C.Recruiting
  • Vumc Amsterdam Medical CenterRecruiting
  • Gelre Ziekenhuizen ApeldoornRecruiting
  • Reinier de Graaf ZiekenhuisRecruiting
  • Het Van Weel Bethesda ziekenhuisRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Bethesda Diabetes Research CenterRecruiting
  • Canisius-Wilhelmina Ziekenhuis (CWZ)Recruiting
  • Centrum Medyczne PratiaRecruiting
  • Clinical Best SolutionsRecruiting
  • Etg LublinRecruiting
  • Centrum Zdrowia MetabolicznegoRecruiting
  • Clinical Best Solutions Sp. Z.o.o Spolka KomandytowaRecruiting
  • Centrum Medycnze AMEDRecruiting
  • ETG Zamosc / Pro Life Medica Sp. z o.o.Recruiting
  • Centra Medyczne MedyceuszRecruiting
  • Hospital CUF TejoRecruiting
  • Centro Hospitalar de Entre Douro e VougaRecruiting
  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.LRecruiting
  • S.C. SAL MED S.R.L., CardiologieRecruiting
  • Alian s.r.o.Recruiting
  • Ambulancia diabetologicka a poruch latkovej premeny a vyzivyRecruiting
  • Interna a diabetologicka ambulancia - IN-DIA s.r.o.Recruiting
  • Diab sroRecruiting
  • Interna SK, s.r.o.Recruiting
  • Areteus s.r.oRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital Vall d'HebronRecruiting
  • Hospital Comarcal Infanta ElenaRecruiting
  • Hospital Universitario de JaenRecruiting
  • Hospital Regional de MalagaRecruiting
  • Unidad de Ensayos ClinicosRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Acardo MedSiteRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Recruiting
  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olezarsen

Placebo

Arm Description

Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.

Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo

Secondary Outcome Measures

Percent Change from Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) Compared to Placebo
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
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
Percentage of Participants Achieving Fasting TG < 1000 mg/dL in Participants with Baseline TG ≥ 1000 mg
Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III) at 6 and 12 Months Compared to Placebo
Percent Change from Baseline in Fasting Very Low-Density Lipoprotein Cholesterol (VLDL-C) at 6 and 12 Months Compared to Placebo
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at 6 and 12 Months Compared to Placebo
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at 6 and 12 Months Compared to Placebo
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
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
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo

Full Information

First Posted
September 20, 2022
Last Updated
October 18, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05552326
Brief Title
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
Keywords
Hypertriglyceridemia, Hyperlipidemias, Metabolic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olezarsen
Arm Type
Experimental
Arm Description
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Intervention Type
Drug
Intervention Name(s)
Olezarsen
Other Intervention Name(s)
ISIS 678354, AKCEA-APOCIII-LRx
Intervention Description
Olezarsen will be administered by SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Olezarsen-matching placebo will be administered by SC injection.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Percentage of Participants Achieving Fasting TG < 1000 mg/dL in Participants with Baseline TG ≥ 1000 mg
Time Frame
Month 6 and Month 12
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Time Frame
Week 1 through Week 53
Title
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo
Time Frame
Week 13 through Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification 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. Participants must be willing to comply with diet and lifestyle recommendations as able. Exclusion Criteria: Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome Estimated GFR < 30 mL/min/1.73 m^2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ionis Pharmaceuticals
Phone
844-366-0213
Email
ionisSHTG2study@clinicaltrialmedia.com
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Alabama Clinical Therapeutics, LLC Alabaster
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Finlay Medical Research
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Clinical Services
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Harmony Clinical Research, Inc
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Combined Research Orlando Phase I-IV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Name
3Sync Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33325
Country
United States
Individual Site Status
Recruiting
Facility Name
R & B Medical Center LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
JSV Clinical Research Study, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Recruiting
Facility Name
Metabolic Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Clinical Research
City
Eatonton
State/Province
Georgia
ZIP/Postal Code
31024
Country
United States
Individual Site Status
Recruiting
Facility Name
Randomize Now
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent Medical Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Name
Grace Research, LLC
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of America LA, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Cardiovascular Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Name
Orchard Park Family Practice
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of America, LLC
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Individual Site Status
Recruiting
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University (OSU)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Individual Site Status
Recruiting
Facility Name
SV Research LLC
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Main Street Physicians Care Waterway
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Individual Site Status
Recruiting
Facility Name
Monument Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Health Family Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Individual Site Status
Recruiting
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT - McAllen Primary Care, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
McAllen Primary Care, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Institute of Cardiology
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Individual Site Status
Recruiting
Facility Name
Diabetes & Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Tranquil Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Investigation Specialists Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Individual Site Status
Recruiting
Facility Name
MHAT Haskovo AD
City
Haskovo
ZIP/Postal Code
6304
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT - Kaspela EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Pulmed OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Kanev AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Sliven to MMA Sofia
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Zara - Med
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Equita
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Cardiology
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
NL Health Services
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Aggarwal and Associates Ltd.
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Joanne F. Liutkus Medicine Professional Corporation
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3H 4L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Bluewater Clinical Research Group
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7t 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
CTC Hodonin s.r.o.
City
Hodonín
ZIP/Postal Code
695 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
KardioBusak s.r.o.
City
Louny
ZIP/Postal Code
440 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Endokrinologie Cerny Most s.r.o.
City
Praha
ZIP/Postal Code
198 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Diabetologická a endokrinologická ambulance Milan Kvapil
City
Příbram
ZIP/Postal Code
267 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
AeskuLab k.s
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hopital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
ELSAN - Polyclinique Vauban
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Individual Site Status
Recruiting
Facility Name
GHM les Portes du Sud
City
Vénissieux
ZIP/Postal Code
69200
Country
France
Individual Site Status
Recruiting
Facility Name
Lausmed Kft.
City
Baja
ZIP/Postal Code
H-6500
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
H1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pharma4 Trial Kft.
City
Gyöngyös
ZIP/Postal Code
H-3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Saules seimons medicinos centras
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Clinic of Cardiology and Rehabilitation
City
Klaipėda
ZIP/Postal Code
LT-91131
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Sultanah Bahiyah Hospital
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Taiping
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pulau Pinang Hospital
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre (UMMC)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Medical Care and Research S.A de C.V.
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Cientia Investigacion Clinica Sc
City
Chihuahua
ZIP/Postal Code
32103
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinstile, S.A. de C.V.
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute S.C.
City
Tlanepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Vumc Amsterdam Medical Center
City
Amsterdam
ZIP/Postal Code
1081BT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Gelre Ziekenhuizen Apeldoorn
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Reinier de Graaf Ziekenhuis
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Het Van Weel Bethesda ziekenhuis
City
Dirksland
ZIP/Postal Code
3247BW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Bethesda Diabetes Research Center
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina Ziekenhuis (CWZ)
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Best Solutions
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Individual Site Status
Recruiting
Facility Name
Etg Lublin
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Zdrowia Metabolicznego
City
Poznan
ZIP/Postal Code
60-589
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Best Solutions Sp. Z.o.o Spolka Komandytowa
City
Warsaw
ZIP/Postal Code
00-710
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medycnze AMED
City
Warsaw
ZIP/Postal Code
03-291
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETG Zamosc / Pro Life Medica Sp. z o.o.
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centra Medyczne Medyceusz
City
Łódź
ZIP/Postal Code
91-053
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital CUF Tejo
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Entre Douro e Vouga
City
Santa Maria Da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
City
Braşov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
S.C. SAL MED S.R.L., Cardiologie
City
Piteşti
ZIP/Postal Code
10437
Country
Romania
Individual Site Status
Recruiting
Facility Name
Alian s.r.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
City
Bratislava
ZIP/Postal Code
83106
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Interna a diabetologicka ambulancia - IN-DIA s.r.o.
City
Lučenec
ZIP/Postal Code
98401
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Diab sro
City
Rožňava
ZIP/Postal Code
04801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Interna SK, s.r.o.
City
Svidník
ZIP/Postal Code
08901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Areteus s.r.o
City
Trebišov
ZIP/Postal Code
07501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Comarcal Infanta Elena
City
Huelva
ZIP/Postal Code
21007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Jaen
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional de Malaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Unidad de Ensayos Clinicos
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Acardo MedSite
City
Solna
ZIP/Postal Code
SE-171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
New Taipei City
ZIP/Postal Code
251404
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

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