NCT03397121

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

Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-08-27
• Completion: 2019-09-17
• First posted: 2018-01-11
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

45 sites across 8 countries: United States, Canada, Czechia, Denmark, Netherlands, South Africa, Spain, Sweden

Regulatory

• FDA-regulated drug study