Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

Conditions

• ASCVD
• Elevated Cholesterol
• Heterozygous Familial Hypercholesterolemia
• Homozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inclisiran Sodium — DRUG
  Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Study Details

The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.

Key Dates

Start date

Apr 16, 2019

Status verified

Feb 2024

Primary completion

Feb 13, 2023

Completion

Feb 13, 2023

Study Design

Enrollment

3,275 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Inclisiran
  Inclisiran sodium 300 milligrams (mg) was administered as a single SC injection on Day 1\*, 90, then every 180 days to Day 990. \*Subjects who received blinded placebo in the feeder study received blinded inclisiran and subjects who received blinded inclisiran in the feeder study received blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-3 study did not receive any injection of study drug on Day 1. Their first dose of study medication was at day 90

Primary Outcome Measure

Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk [ Time Frame: From ORION-8 Day 1 to the end of study (up to 1080 days) ]

Locations (141)

Find similar trials in Birmingham, AL

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