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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: LIB003

• Registration Number: NCT03847974
• Lead Sponsor: LIB Therapeutics LLC

Brief Summary

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)

Detailed Description

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

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2020-04-07
• Study Completion: 2020-08-31
• Results First Submitted: 2022-01-17
• Results First Submitted QC: 2022-01-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-02-10
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. men and women 18 years or older
2. 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)
3. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LIB003	LIB003	LIB003

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	52 weeks	safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Percent Change in LDL-C at 52 Weeks	52 weeks	percent change in serum LDL-C from baseline at 52 weeks

Trial Locations

Locations (3)

Sterling Research Group; 🇺🇸 Cincinnati, Ohio, United States

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

The Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States