Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

Sponsor
LIB Therapeutics LLC
Study ID
NCT05004675
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lerodalcibep — BIOLOGICAL
    300 mg
  • Inclisiran — DRUG
    284 mg

Study Details

Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

Key Dates

Start date
Jun 20, 2022
Status verified
Oct 2024
Primary completion
May 30, 2024
Completion
Oct 15, 2024

Study Design

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

Arms

  • Experimental: lerodalcibep
    300 mg SC dosed monthly
  • Active Comparator: inclisiran
    284 mg SC dosed Day 1 and Day 90

Primary Outcome Measure

LDL-C change [ Time Frame: Day 270 ]

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