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OpenTrials
Completed

NCT Number: NCT03847974

Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Metabolic & Atherosclerosis Research Center (MARC), Cincinnati, Ohio, United States

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About this study

To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women 18 years or older
  • Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
  • patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion criteria

  • patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
  • <18 years of age
  • pregnant or women of childbearing potential not using acceptable birth control

Treatment and study plan

LIB003

Drug

300 mg SC Q4W

Other names: lerodalcibep

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 52 weeks

    safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Secondary outcomes

  1. Percent Change in LDL-C at 52 Weeks

    Time frame: 52 weeks

    percent change in serum LDL-C from baseline at 52 weeks

Sponsors and collaborators

Lead sponsor

LIB Therapeutics LLC

Industry

Registry information

Official study title

Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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