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Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

NCT03156621 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-06-29

Study results available
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Summary

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.

The secondary objectives of the study are:

* To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein \[Apo\] A-1 and B, non-high-density lipoprotein cholesterol \[non-HDL-C\], total-cholesterol \[TC\], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides \[TG\]) in participants with HoFH
* To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH
* To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH
* To assess the potential development of anti-drug (alirocumab) antibodies

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

Alirocumab

Alirocumab SC Q2W

DRUG

Placebo

Matching placebo SC Q2W

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2019-09-27
Completion
2020-02-13
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • 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 NCT03156621 on ClinicalTrials.gov