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CTRI Number  CTRI/2021/11/037835 [Registered on: 08/11/2021] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   An open label extension study to evaluate the long term efficacy and safety of LIB-003 in patients with familial hypercholesterolemia, very high or high risk for cardiovascular disease who are on stable lipid-lowering therapy requiring additional LDL-C reduction (LIBerate-OLE). 
Scientific Title of Study   Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LIB003-007 Version 1.0 dated 3November2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Vimal mehta 
Designation  professor of Cardiology 
Affiliation  G .B. Pant Institute of Postgraduate Medical Education & Research, 
Address  Room No.-133, 1st Floor, Academic Block, Department of Cardiology, Jawahar Lal Nehru Marg, New Delhi-, India

New Delhi
DELHI
110002
India 
Phone  9718599105  
Fax    
Email  drvimalmehta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vimal mehta 
Designation  professor of Cardiology 
Affiliation  G .B. Pant Institute of Postgraduate Medical Education & Research, 
Address  Room No.-133, 1st Floor, Academic Block, Department of Cardiology, Jawahar Lal Nehru Marg, New Delhi-, India

New Delhi
DELHI
110002
India 
Phone  9718599105  
Fax    
Email  drvimalmehta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jyoti Kulaye 
Designation   
Affiliation  Medpace Clinical Research India Pvt. Ltd. 
Address  Office No. 817, 8th Floor Rupa Solitaire Building No. A-1, Sector-1 Millenium Business Park Next to DAKC, Mahape Navi Mumbai 400710

Thane
MAHARASHTRA
400710
India 
Phone  9930146108  
Fax    
Email  j.kulaye@medpace.com  
 
Source of Monetary or Material Support  
LIB Therapeutics, LLC 5375 Medpace Way Cincinnati, OH 45227 
 
Primary Sponsor  
Name  LIB Therapeutics LLC 
Address  5375 Medpace Way Cincinnati, OH 45227 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
France
Germany
India
Israel
New Zealand
Norway
South Africa
Spain
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milan Chinubhai Chag  Care Institute of Medical Sciences   Near. Shukan Mall, Off. Science City Road, Sola , Ahmedabad
Ahmadabad
GUJARAT 		 7930101166
7927712777
milan.chag@cims.me 
Dr Aditya Kapoor  Department of Cardiology  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road , Lucknow
New Delhi
DELHI 		 5222668700

akapoor65@gmail.com 
Dr Vimal Mehta  G .B. Pant Institute of Postgraduate Medical Education & Research  Room No.-133, 1st Floor, Academic Block, Department of Cardiology,
New Delhi
DELHI 		 91-9718599105
011-23212554
drvimalmehta@yahoo.co.in 
Dr Raman Puri  Indraprastha Apollo Hospital   Sarita Vihar, Mathura Road
New Delhi
DELHI 		 91-9871071919

lipidaoi@gmail.com 
Dr Akshaya Pradhan  King Georges Medical University  Dept of Cardiology, King Georges Medical University, Lucknow-226003, India
Lucknow
UTTAR PRADESH 		 8400813739

akshyaya33@gmail.com 
Dr Ashwani Mehta  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Rajinder Nagar
New Delhi
DELHI 		 9811057384

drashwanimehta@gmail.com 
Dr Preeti Gupta  Vardhman Mahavir Medical College and Safdarjung Hospital  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi110029
New Delhi
DELHI 		 9350457434

drpreetisjh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics committee of Care Institute of Medical Sciences CIMS Hospital Pvt. Ltd  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee ,Office of the Research Cell, King George’s Medical University   Approved 
Institutional Ethics Committee -Clinical studies   Approved 
Institutional Ethics Committee VMMC and Safdarjung Hospital  Approved 
Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences  Not Applicable 
SirGanga Ram Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E783||Hyperchylomicronemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LIB003  SC injection in either the abdomen, thigh or upper arm (which may be rotated) on Week 0 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. 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
2.Provision of written and signed informed consent prior to any study-specific procedure;
3. 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;
4. 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
5. Patient is considered by the Investigator to be otherwise healthy, 
 
ExclusionCriteria 
Details  1. 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;
2. 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 Investigaton 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks  72 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity
LDL Cholesterol reduction 		 72 weeks
72 weeks 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   06/04/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/12/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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