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

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NCT05681351 · readout ≤ 224 d

Sponsored by Ionis Pharmaceuticals, Inc. (industry) · IONS — their whole pipeline →.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Na · None · Treatment

Enrollment

885actual

Sites

262

Countries

Argentina, Australia, Belgium +30

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-12-13

actual

When the study began enrolling

Primary completion

Mar 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Mar 2027

estimated

The whole study's end, after follow-up

First posted

2023-01-12

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-12-01

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Severe Hypertriglyceridemia

Intervention

Drug: Olezarsen — also filed as AKCEA-APOCIII-LRx, ISIS 678354

Primary outcomes

what the primary-completion date above is the date OF

Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157

measured Baseline up to Week 157

Proportion of Participants Who Experience Adverse Events (AEs)

measured Baseline up to Week 157

Proportion of Participants Who Use Concomitant Medications

measured Baseline up to Week 157

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