Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
LIB Therapeutics LLC
Study ID
NCT04806893
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • lerodalcibep — DRUG
    300 mg subcutaneous injection every month (Q4W)
  • Placebo — OTHER
    matching subcutaneous injection every month (Q4W)

Study Details

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy

Key Dates

Start date
Apr 22, 2021
Status verified
Dec 2023
Primary completion
Nov 15, 2023
Completion
Feb 28, 2024

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LIB003 (lerodalcibep)
    300 mg subcutaneously monthly (Q4W)
  • Placebo Comparator: Placebo
    matching placebo subcutaneously monthly (Q4W)

Primary Outcome Measure

LDL-C change compared to placebo [ Time Frame: 52 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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