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

Phase 3

Completed

• Conditions: Homozygous Familial Hypercholesterolemia
• Interventions: Drug: lerodalcibep; Drug: evolocumab

• Registration Number: NCT04034485
• Lead Sponsor: LIB Therapeutics LLC

Brief 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

Detailed Description

Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B).

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2019-12-07
• Primary Completion: 2022-09-12
• Study Completion: 2023-01-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LIB003 (lerodalcibep)	lerodalcibep	300 mg SC Q4W
evolocumab	evolocumab	420 mg SC Q4W

Primary Outcome Measures

Name	Time	Method
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24	baseline to 24 weeks on each treatment	Change in serum LDL-C from baseline after 24 weeks

Secondary Outcome Measures

Name	Time	Method
The incidence and severity of treatment emergent adverse events (TEAEs)	baseline to 24 weeks on each treatment	safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Trial Locations

Locations (12)

Department of Medicine, Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Division of Lipidology, Department of Medicine University of Cape Town; 🇿🇦 Cape Town, Western Province, South Africa

Ege University Medical School; 🇹🇷 İzmir, Bornova, Turkey

Afyonkarahisar Health Sciences University; 🇹🇷 Afyon, Turkey

Rabin Medical Center, Beilinson Hospital,; 🇮🇱 Petah Tikva, Israel

Lipid Clinic, Oslo University Hospital; 🇳🇴 Oslo, Norway

VMMC & Safdarjung Hospital; 🇮🇳 Delhi, NCT, India

G.B. Pant Institute of Postgraduate Medical Education & Research; 🇮🇳 New Delhi, India

CIMS Hospital Pvt. Ltd; 🇮🇳 Ahmedabad, India

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

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

Carbohydrate and Lipid Metabolism Research Unit; 🇿🇦 Johannesburg, Gauteng, South Africa