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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
LIB Therapeutics LLC
Study ID
NCT04034485
Phase
PHASE3
Status
Completed

Conditions

  • Homozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lerodalcibep — DRUG
    PCSK9 inhibitor
  • evolocumab — DRUG
    PCSK9 inhibitor

Study Details

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

Key Dates

Start date
Dec 7, 2019
Status verified
Mar 2023
Primary completion
Sep 12, 2022
Completion
Jan 30, 2023

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: LIB003 (lerodalcibep)
    300 mg SC Q4W
  • Active Comparator: evolocumab
    420 mg SC Q4W

Primary Outcome Measure

Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24 [ Time Frame: baseline to 24 weeks on each treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
NorthShore University Health SystemEvanstonIllinois60201-
Metabolic & Atherosclerosis Research Center (MARC)CincinnatiOhio45227-

Find similar trials in Evanston, IL

By research site
NorthShore University Health System· Evanston, ILMetabolic & Atherosclerosis Research Center (MARC)· Cincinnati, OH

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