ClinicalTrials.Veeva

Menu
The trial is taking place at:
C

Canadian Phase Onward | Toronto, Canada

Veeva-enabled site

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

Ionis Pharmaceuticals logo

Ionis Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Severe Hypertriglyceridemia

Treatments

Drug: Olezarsen

Study type

Interventional

Funder types

Industry

Identifiers

NCT05681351
2022-501999-26-00 (Other Identifier)
ISIS 678354-CS15

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

700 participants in 1 patient group

Olezarsen
Experimental group
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.
Treatment:
Drug: Olezarsen

Trial contacts and locations

107

Loading...

Central trial contact

Ionis Pharmaceuticals, Inc.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems