Overview

Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

Status:
Active, not recruiting

Trial end date:
2022-07-30

Target enrollment:
0

Participant gender:
All

Summary

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

LIB Therapeutics LLC

Treatments:

Antibodies, Monoclonal
Evolocumab

Criteria

Inclusion Criteria:

- HoFH diagnosed clinically and confirmed by genotyping

- Weight of >30 kg and body mass index (BMI) >17 and <40 kg/m2

- stable diet and lipid-lowering oral therapies for at least 4 weeks

Exclusion Criteria:

- mipomersen within 6 months of screening;

- LDL or plasma apheresis <2 months prior to randomization

- history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR
activity expected to result in non-response to PCSK9 inhibition

- prior or active clinical condition or acute and/or unstable systemic disease
compromising subject inclusion