NCT03847974

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	LIB003	300 mg SC Q4W

Timeline

• Start date: 2019-02-14
• Primary completion: 2020-04-07
• Completion: 2020-08-31
• First posted: 2019-02-20
• Last updated: 2022-03-02
• Results posted: 2022-02-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study