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A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Primary Purpose

Severe Hypertriglyceridemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olezarsen
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 ISIS 678354, Olezarsen

Eligibility Criteria

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

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. 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.

Sites / Locations

  • Excel Medical Clinical TrialsRecruiting
  • Bayside Clinical ResearchRecruiting
  • Centricity ResearchRecruiting
  • Affinity HealthRecruiting
  • University of Kansas Medical Center (KUMC)Recruiting
  • University of Michigan- Endocrinology & MetabolismRecruiting
  • Aa Mrc, LlcRecruiting
  • The Presbyterian Hospital DBA Novant Health Heart and Vascular InstituteRecruiting
  • Kenneth HiltyRecruiting
  • Central Oklahoma Early Detection CenterRecruiting
  • Health ConceptsRecruiting
  • University of Texas SouthwesternRecruiting
  • Manassas Clinical ResearchRecruiting
  • York Clinical ResearchRecruiting
  • Canadian Phase Onward Inc.Recruiting
  • Ecogene-21Recruiting
  • Medifarma-98 Kft.Recruiting
  • New Zealand Clinical ResearchRecruiting
  • Latros InternationalRecruiting
  • Medi Clinic VergelegenRecruiting
  • TREAD ResearchRecruiting
  • Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olezarsen

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53
Proportion of Participants Who Experience Adverse Events (AEs)
Proportion of Participants Who Use Concomitant Medications

Secondary Outcome Measures

Full Information

First Posted
December 25, 2022
Last Updated
October 4, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05681351
Brief Title
A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Official Title
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
September 2026 (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 safety and tolerability of olezarsen in participants with SHTG.
Detailed Description
This is a multi-center, open-label study of up to 700 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period. The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
Keywords
ISIS 678354, Olezarsen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olezarsen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Olezarsen
Other Intervention Name(s)
AKCEA-APOCIII-LRx, ISIS 678354
Intervention Description
Administered as SC injection.
Primary Outcome Measure Information:
Title
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53
Time Frame
Baseline up to Week 53
Title
Proportion of Participants Who Experience Adverse Events (AEs)
Time Frame
Up to 66 weeks
Title
Proportion of Participants Who Use Concomitant Medications
Time Frame
Up to 66 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ionis Pharmaceuticals, Inc.
Phone
(844) 274-0709
Email
ionisSHTG3study@clinicaltrialmedia.com
Facility Information:
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Name
Bayside Clinical Research
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Affinity Health
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center (KUMC)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan- Endocrinology & Metabolism
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Aa Mrc, Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Kenneth Hilty
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Oklahoma Early Detection Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Manassas Clinical Research
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Name
York Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Recruiting
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J2C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Medifarma-98 Kft.
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
New Zealand Clinical Research
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Latros International
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Medi Clinic Vergelegen
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
TREAD Research
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

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