Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

NCT04798430 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: LIB003-007
• Study Type: interventional
• Target: 2,000
• Locations: 6 countries
• Sites: 12

Brief Summary

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

Conditions

Cardiovascular Disease With Mention of Arteriosclerosis; Elevated Cholesterol; Familial Hypercholesterolemia

Keywords

lerodalcibep; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks

  Evaluation of Adverse Events based on MedRA based on ITT population

  72 weeks

Secondary Outcomes (2)

• Immunogenicity

  72 weeks

• LDL Cholesterol reduction

  72 weeks

Study Arms (1)

LIB003 (lerodalcibep)

EXPERIMENTAL

300 mg monthly (Q4W) by subcutaneous injection

Drug: lerodalcibep

Interventions

lerodalcibep DRUG

PCSK9 inhibitor

Also known as: LIB003

LIB003 (lerodalcibep)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful completion 1 of one of the Phase 3 base studies LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to LIB003; or
• Provision of written and signed informed consent prior to any study-specific procedure;
• Female patients of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing;
• Patient is willing to maintain appropriate diet and stable dose of current lipid-lowering therapy including statins, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and
• Patient is considered by the Investigator to be otherwise healthy,

You may not qualify if:

• Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to study drug during the base Phase 3 study;
• Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months;
• Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
• Has any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;

Sponsors & Collaborators

• LIB Therapeutics LLC: lead
• Medpace, Inc.: collaborator

Study Sites (12)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, 45227, United States

Location

G.B. Pant Institute of Postgraduate Medical Education & Research

New Delhi, 110002, India

Location

Department of Medicine, Hadassah University Hospital

Jerusalem, 12000, Israel

Location

Rabin Medical Center, Beilinson Hospital,

Petah Tikva, 49100, Israel

Location

Lipid Clinic, Oslo University Hospital

Oslo, 0586, Norway

Location

Carbohydrate and Lipid Metabolism Research Unit

Johannesburg, Gauteng, 2193, South Africa

Location

Division of Lipidology, Department of Medicine University of Cape Town

Cape Town, Western Province, 7925, South Africa

Location

Ege University Medical School

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Afyonkarahisar Health Sciences University

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Study Officials

• David Kallend, MB BCh

  LIB Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: lipids blinded to participant, investigator and sponsor at Day 1 only
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label extension trial

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: December 3, 2020
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); TU (2); IN (1); US (4); ZA (2); IL (2)