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Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT03397121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2020-10-28

Study results available
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Summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.

Conditions

  • Heterozygous Familial Hypercholesterolemia
  • Elevated Cholesterol

Interventions

DRUG

Inclisiran

Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

DRUG

Placebo

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

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Frederick J. Raal, MD · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2019-08-27
Completion
2019-09-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Netherlands
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397121 on ClinicalTrials.gov