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Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

NCT04034485 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-03-29

No results posted yet for this study

Summary

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks \[Q4W\]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

lerodalcibep

PCSK9 inhibitor

DRUG

evolocumab

PCSK9 inhibitor

Sponsors & Collaborators

  • LIB Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Evan A Stein, MD PhD · LIB Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-07
Primary Completion
2022-09-12
Completion
2023-01-30
FDA Drug
Yes

Countries

  • United States
  • India
  • Israel
  • Norway
  • South Africa
  • Turkey (Türkiye)

Study Locations

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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 NCT04034485 on ClinicalTrials.gov