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ISIS 678354-CS9: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503022-13-00
Acronym
ISIS 678354-CS9
Enrollment
577
Registered
2023-05-16
Start date
2023-06-08
Completion date
2025-05-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis

Brief summary

Percent change in fasting TG from Baseline at Week 25 compared to placebo.

Detailed description

Percent change in fasting TG from Baseline at Week 53 compared to placebo, Proportion of patients who achieve fasting TG < 150 mg/dL (1. 69 mmol/L) at Week 25 and proportion of patients who achieve fasting TG < 150 mg/dL at Week 53 compared to placebo, Percent change in fasting apoC-III, VLDL-C, remnant cholesterol, non-HDL-C, HDL-C, apoB, and LDL-C from Baseline at Week 25 and at Week 53 compared to placebo, Safety and tolerability assessments include: adverse events (AEs), vital signs and weight, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and use of concomitant medications. Safety and tolerability results in patients receiving olezarsen will be compared with those receiving placebo.

Interventions

DRUGPlacebo lnjection
DRUG1.5 ug/ml Riboflavin
DRUG0.8ml

Sponsors

Ionis Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change in fasting TG from Baseline at Week 25 compared to placebo.

Secondary

MeasureTime frame
Percent change in fasting TG from Baseline at Week 53 compared to placebo, Proportion of patients who achieve fasting TG < 150 mg/dL (1. 69 mmol/L) at Week 25 and proportion of patients who achieve fasting TG < 150 mg/dL at Week 53 compared to placebo, Percent change in fasting apoC-III, VLDL-C, remnant cholesterol, non-HDL-C, HDL-C, apoB, and LDL-C from Baseline at Week 25 and at Week 53 compared to placebo, Safety and tolerability assessments include: adverse events (AEs), vital signs and weight, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and use of concomitant medications. Safety and tolerability results in patients receiving olezarsen will be compared with those receiving placebo.

Countries

Bulgaria, Czechia, Denmark, Finland, France, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026