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A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

NCT03851705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-01-30

Study results available
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Summary

This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

Inclisiran Sodium for injection

Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.

DRUG

Placebo

Sterile normal saline (0.9% sodium chloride in water for injection)

DRUG

Placebos

Sterile normal saline (0.9% sodium chloride in water for injection)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2020-03-02
Completion
2021-09-09
FDA Drug
Yes

Countries

  • Hong Kong
  • Israel
  • Russia
  • Serbia
  • South Africa
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03851705 on ClinicalTrials.gov