Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
LIB Therapeutics LLC
Study ID
NCT04790513
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lerodalcibep — BIOLOGICAL
    anti-PCSK9 small binding protein
  • evolocumab — BIOLOGICAL
    monoclonal antibody to PCSK9
  • alirocumab — BIOLOGICAL
    monoclonal antibody to PCSK9

Study Details

Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.

Key Dates

Start date
Apr 22, 2021
Status verified
Mar 2023
Primary completion
Sep 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

LDL-C reduction from baseline at 12 weeks [ Time Frame: 12 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Metabolic & Atherosclerosis Research Center (MARC)CincinnatiOhio45227-
Sterling Research GroupCincinnatiOhio45219-
The Lindner Research CenterCincinnatiOhio45219-

Find similar trials in Cincinnati, OH

By research site
Metabolic & Atherosclerosis Research Center (MARC)· Cincinnati, OHSterling Research Group· Cincinnati, OHThe Lindner Research Center· Cincinnati, OH

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