ISIS 678354 CS6- Phase 3 Study of Olezarsen (ISIS 678354) Administered SC to patients w/ SHTG

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia

• IRAS ID

  1006430

• Contact name

  Stacy Woeppel

• Contact email

  swoeppel@ionisph.com

• Sponsor organisation

  Ionis Pharmaceuticals, Inc.

• Eudract number

  2022-501420-20

• Clinicaltrials.gov Identifier

  NCT05552326

• Research summary

  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 74 weeks, which includes an up to 8-week screening period, a 53-week treatment period, and a 13-week posttreatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

• REC name

  Wales REC 1

• REC reference

  23/WA/0038

• Date of REC Opinion

  21 Sep 2023

• REC opinion

  Further Information Unfavourable Opinion