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

Phase 1

Recruiting

• Conditions: Severe Hypertriglyceridemia (SHTG); MedDRA version: 20.1Level: LLTClassification code: 10020870Term: Hypertriglyceridemia Class: 10027433; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2022-501999-26-00
• Lead Sponsor: Ionis Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 935

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified