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Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction

NCT04797247 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2023-12-11

No results posted yet for this study

Summary

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 very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.

Conditions

Interventions

DRUG

lerodalcibep

PCSK9 inhibitor

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • LIB Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Evan A Stein, MD PhD · LIB Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2023-11-15
Completion
2024-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04797247 on ClinicalTrials.gov