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3Sync Research | Palm Beach Clinic

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A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Ionis Pharmaceuticals logo

Ionis Pharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

Hypertriglyceridemia
Cardiovascular Diseases
Atherosclerosis

Treatments

Drug: Placebo
Drug: Olezarsen

Study type

Interventional

Funder types

Industry

Identifiers

NCT05610280
2022-501486-53 (EudraCT Number)
ISIS 678354-CS9

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

Full description

This is a Phase 3, multi-center, placebo-controlled study in approximately 1475 participants with hypertriglyceridemia and atherosclerotic cardiovascular disease. The study consists of 3 periods: 1) Screening Period: Week -12 to Week -1 (up to 12 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen or placebo once every 4 weeks during the 53-week Treatment Period.

The Screening Period was extended with no impact to overall study timelines.

A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.

Enrollment

1,478 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must fall into 1 of the following groups (a or b):

    a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter [mmol/L]) and <500 mg/dL (5.65 mmol/L) with either

  • Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or

  • At increased risk for ASCVD

    b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)

  • Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.

Exclusion criteria

  • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  • Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  • Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome
  • Estimated GFR < 30 mL/min/1.73 m^2

NOTE: Other Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,478 participants in 2 patient groups, including a placebo group

Olezarsen
Experimental group
Description:
Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection up to Week 49.
Treatment:
Drug: Olezarsen
Placebo
Placebo Comparator group
Description:
Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection up to Week 49.
Treatment:
Drug: Placebo

Trial contacts and locations

167

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Central trial contact

Ionis Pharmaceuticals

Data sourced from clinicaltrials.gov

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