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

NCT05004675 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-10-23

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

lerodalcibep

300 mg

DRUG

Inclisiran

284 mg

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
2022-06-20
Primary Completion
2024-05-30
Completion
2024-10-15
FDA Drug
Yes

Countries

  • France
  • Germany
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT05004675 on ClinicalTrials.gov