Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

Conditions

• ASCVD
• Elevated Cholesterol

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.
• Placebo — DRUG
  Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Study Details

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

Key Dates

Start date

Dec 21, 2017

Status verified

Sep 2020

Primary completion

Sep 10, 2019

Completion

Sep 17, 2019

Study Design

Enrollment

1,561 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inclisiran
  Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
• Placebo Comparator: Saline Solution
  Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Primary Outcome Measure

Percentage Change in LDL-C From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]

Locations (145)

Find similar trials in Birmingham, AL

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