Back to resultsLong-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction (LIBerate-OLE)
Primary Purpose
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lerodalcibep
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease With Mention of Arteriosclerosis focused on measuring lerodalcibep, PCSK9 inhibitor
Eligibility Criteria
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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;
- Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator,
- 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;
Sites / Locations
- NorthShore University Health System
- Sterling Research Group
- The Lindner Research Center
- Metabolic & Atherosclerosis Research Center (MARC)
- G.B. Pant Institute of Postgraduate Medical Education & Research
- Department of Medicine, Hadassah University Hospital
- Rabin Medical Center, Beilinson Hospital,
- Lipid Clinic, Oslo University Hospital
- Carbohydrate and Lipid Metabolism Research Unit
- Division of Lipidology, Department of Medicine University of Cape Town
- Ege University Medical School
- Afyonkarahisar Health Sciences University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LIB003 (lerodalcibep)
Arm Description
300 mg monthly (Q4W) by subcutaneous injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Immunogenicity
Incidence of anti-drug antibodies
LDL Cholesterol reduction
Percent decrease in LDL-C from baseline of original study
Full Information
NCT ID
NCT04798430
First Posted
March 9, 2021
Last Updated
March 27, 2023
Sponsor
LIB Therapeutics LLC
Collaborators
Medpace, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04798430
Brief Title
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Acronym
LIBerate-OLE
Official Title
Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LIB Therapeutics LLC
Collaborators
Medpace, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012). Patients will continue to maintain their existing oral lipid-lowering therapy (LLT).
Following completion of a base study and providing informed consent, patients will receive doses of LIB003 300 mg Q4W (<31 days) on Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68. Patients will be seen in the clinic Q4W (<31 days) for at least the initial 12 weeks and then every 12 weeks (Weeks 24, 36, 48, 60, and 72) with the interim Q4W (<31 days) doses administered at home.
Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial. Their lipids will remain blinded (to patient, study staff and sponsor) until week 4 to avoid any unblinding of the prior trial. Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
Keywords
lerodalcibep, PCSK9 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open label extension trial
Masking
None (Open Label)
Masking Description
lipids blinded to participant, investigator and sponsor at Day 1 only
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LIB003 (lerodalcibep)
Arm Type
Experimental
Arm Description
300 mg monthly (Q4W) by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
lerodalcibep
Other Intervention Name(s)
LIB003
Intervention Description
PCSK9 inhibitor
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks
Description
Evaluation of Adverse Events based on MedRA based on ITT population
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Incidence of anti-drug antibodies
Time Frame
72 weeks
Title
LDL Cholesterol reduction
Description
Percent decrease in LDL-C from baseline of original study
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
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;
Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator,
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kallend, MB BCh
Organizational Affiliation
LIB Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metabolic & Atherosclerosis Research Center (MARC)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
G.B. Pant Institute of Postgraduate Medical Education & Research
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Department of Medicine, Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital,
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Lipid Clinic, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Carbohydrate and Lipid Metabolism Research Unit
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Division of Lipidology, Department of Medicine University of Cape Town
City
Cape Town
State/Province
Western Province
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Ege University Medical School
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Afyonkarahisar Health Sciences University
City
Afyon
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
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