Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05681351




Registration number
NCT05681351
Ethics application status
Date submitted
25/12/2022
Date registered
12/01/2023

Titles & IDs
Public title
A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Scientific title
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Secondary ID [1] 0 0
2022-501999-26-00
Secondary ID [2] 0 0
ISIS 678354-CS15
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Hypertriglyceridemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Olezarsen

Experimental: Olezarsen - Participants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 49.


Treatment: Drugs: Olezarsen
Administered as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53
Timepoint [1] 0 0
Baseline up to Week 53
Primary outcome [2] 0 0
Proportion of Participants Who Experience Adverse Events (AEs)
Timepoint [2] 0 0
Up to 66 weeks
Primary outcome [3] 0 0
Proportion of Participants Who Use Concomitant Medications
Timepoint [3] 0 0
Up to 66 weeks

Eligibility
Key inclusion criteria
* Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment.
* Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria.

NOTE: Other Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Dr Heart Pty Ltd - Woolloongabba
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Burgas
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Dimitrovgrad
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Gabrovo
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Smolyan
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Stara Zagora
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Veliko Tarnovo
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Canada
State/province [29] 0 0
Montréal
Country [30] 0 0
Czechia
State/province [30] 0 0
Brandýs Nad Labem
Country [31] 0 0
Czechia
State/province [31] 0 0
Hradec Králové
Country [32] 0 0
Czechia
State/province [32] 0 0
Náchod
Country [33] 0 0
Czechia
State/province [33] 0 0
Ostrava
Country [34] 0 0
Czechia
State/province [34] 0 0
Prague
Country [35] 0 0
Czechia
State/province [35] 0 0
Uherské Hradište
Country [36] 0 0
Denmark
State/province [36] 0 0
Aalborg
Country [37] 0 0
Denmark
State/province [37] 0 0
Aarhus
Country [38] 0 0
Denmark
State/province [38] 0 0
Esbjerg
Country [39] 0 0
Denmark
State/province [39] 0 0
Viborg
Country [40] 0 0
France
State/province [40] 0 0
Bron
Country [41] 0 0
France
State/province [41] 0 0
Marseille
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Saint-Herblain
Country [44] 0 0
France
State/province [44] 0 0
Valenciennes
Country [45] 0 0
France
State/province [45] 0 0
Vénissieux
Country [46] 0 0
Hungary
State/province [46] 0 0
Balatonfüred
Country [47] 0 0
Hungary
State/province [47] 0 0
Debrecen
Country [48] 0 0
Hungary
State/province [48] 0 0
Nyíregyháza
Country [49] 0 0
Hungary
State/province [49] 0 0
Székesfehérvár
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petach Tikva
Country [53] 0 0
Israel
State/province [53] 0 0
Ramat Gan
Country [54] 0 0
Italy
State/province [54] 0 0
Bologna
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Rome
Country [57] 0 0
Netherlands
State/province [57] 0 0
Amsterdam
Country [58] 0 0
Netherlands
State/province [58] 0 0
Arnhem
Country [59] 0 0
Netherlands
State/province [59] 0 0
Ede
Country [60] 0 0
Netherlands
State/province [60] 0 0
Hoogeveen
Country [61] 0 0
Netherlands
State/province [61] 0 0
Nijmegen
Country [62] 0 0
Netherlands
State/province [62] 0 0
Rotterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
New Zealand
State/province [64] 0 0
Auckland
Country [65] 0 0
New Zealand
State/province [65] 0 0
Wellington
Country [66] 0 0
Norway
State/province [66] 0 0
Oslo
Country [67] 0 0
Poland
State/province [67] 0 0
Katowice
Country [68] 0 0
Poland
State/province [68] 0 0
Lublin
Country [69] 0 0
Poland
State/province [69] 0 0
Poznan
Country [70] 0 0
Poland
State/province [70] 0 0
Wroclaw
Country [71] 0 0
Poland
State/province [71] 0 0
Zamosc
Country [72] 0 0
Portugal
State/province [72] 0 0
Aveiro
Country [73] 0 0
Portugal
State/province [73] 0 0
Porto
Country [74] 0 0
Slovakia
State/province [74] 0 0
Brezno
Country [75] 0 0
Slovakia
State/province [75] 0 0
Košice
Country [76] 0 0
Slovakia
State/province [76] 0 0
Rožnava
Country [77] 0 0
South Africa
State/province [77] 0 0
Bloemfontein
Country [78] 0 0
South Africa
State/province [78] 0 0
Cape Town
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Córdoba
Country [81] 0 0
Spain
State/province [81] 0 0
La Coruna
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Sabadell
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
Tarragona
Country [86] 0 0
Sweden
State/province [86] 0 0
Göteborg
Country [87] 0 0
Sweden
State/province [87] 0 0
Stockholm
Country [88] 0 0
Turkey
State/province [88] 0 0
Sulhiye
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Chatsworth
Country [90] 0 0
United Kingdom
State/province [90] 0 0
England
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Hull

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ionis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ionis Pharmaceuticals, Inc.
Address 0 0
Country 0 0
Phone 0 0
(844) 274-0709
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05681351