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

NCT04806893 · 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 CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy

Conditions

Interventions

DRUG

lerodalcibep

300 mg subcutaneous injection every month (Q4W)

OTHER

Placebo

matching subcutaneous injection every month (Q4W)

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
  • India
  • Israel

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 NCT04806893 on ClinicalTrials.gov