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

Hypercholesterolemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847974
• Other study ID #: LIB003-010
• Status: Completed
• Phase: Phase 2
• Start date: February 14, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2022
• Source: LIB Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 31, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• LIB003
300 mg SC Q4W

Locations

Country	Name	City	State
United States	Metabolic & Atherosclerosis Research Center (MARC)	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	The Lindner Research Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
LIB Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	safety and tolerability will be based on the incidence and severity of treatment emergent adverse events	52 weeks
Secondary	Percent Change in LDL-C at 52 Weeks	percent change in serum LDL-C from baseline at 52 weeks	52 weeks