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CTRI Number  CTRI/2022/01/039679 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Study to evaluate the long-term safety and efficacy of the investigational drug LIB003 for the reduction of cholesterol in patients with Heterozygous Familial Hypercholesterolemia 
Scientific Title of Study   Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Heterozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-HeFH)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
134579-IND  Other 
LIB003-004 Protocol Version 1.0 dated 21/October/2020  Protocol Number 
NCT04797104  ClinicalTrials.gov 
 
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-110002, India

New Delhi
DELHI
110002
India 
Phone  9718599105  
Fax    
Email  drvimalmehta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Vignesh Kotian 
Designation  Regulatory Submission Coordinator 
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  9920831847  
Fax    
Email  V.Kotian@medpace.com  
 
Details of Contact Person
Public Query  
Name  Vignesh Kotian 
Designation  Regulatory Submission Coordinator 
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  9920831847  
Fax    
Email  V.Kotian@medpace.com  
 
Source of Monetary or Material Support  
LIB Therapeutics, LLC 
 
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
India
Israel
New Zealand
Norway
South Africa
Spain
Turkey
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-38060, Gujarat, India
Ahmadabad
GUJARAT 		 7930101166

milan.chag@cims.me 
Dr Aditya Kapoor  Department of Cardiology,  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road , Lucknow 226014
Lucknow
UTTAR PRADESH 		 522668573

akapoor65@gmail.com 
Dr Akshaya Pradhan  Dept of Cardiology, King Georges Medical University  Dept of Cardiology, King Georges Medical University, Lucknow-226003, India
Lucknow
UTTAR PRADESH 		 8400813739

akshyaya33@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

drvimalmehta@yahoo.co.in 
Dr Raman Puri  Indraprastha Apollo Hospital ,  Sarita Vihar, Mathura Road ,New Delhi-110076
New Delhi
DELHI 		 9871071919

lipidaoi@gmail.com 
Dr Ashwani Mehta  Sir Ganga Ram Hospital ,  Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI 		 91-9811057384

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., Opp. Panchmrut Bunglows, Nr. Shukan Mall, Off. Sceicne City Road, Sola, Ahmedabad-380061  Approved 
Institutional Ethics Committee ,Office of the Research Cell, King George’s Medical University Lucknow-226003  Approved 
Institutional Ethics Committee -Clinical studies , Indraprastha Apollo Hospital , Sarita Vihar, Mathura Road ,New Delhi-110076  Approved 
Institutional Ethics Committee VMMC & Safdarjung Hospital Room No. 505 & 506, 5th floor, Main OPD Building, VMMC & Safdarjung Hospital, New Delhi-110029  Approved 
Institutional Ethics Committee, Address: Room No306-A, Maulana Azad Medical College, New Delhi110002, India  Approved 
Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road , Lucknow 226014  Not Applicable 
SirGanga Ram Hospital Ethics Committee, , 6 Floor, Old Building, Old Rajinder Nagar, New Delhi-110060  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LIB003  Study drug (LIB003 or placebo) will be administered by SC injection in either the abdomen, thigh or upper arm (which may be rotated) on Day 1 and Weeks 4, 8, 12, 16, and 20 
Comparator Agent  Placebo  Study drug (LIB003 or placebo) will be administered by SC injection in either the abdomen, thigh or upper arm (which may be rotated) on Day 1 and Weeks 4, 8, 12, 16, and 20 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Provision of written and signed informed consent prior to any study-specific procedure;
2. Weight of ≥40 kg (88 lbs) and body mass index (BMI) ≥17 and ≤42 kg/m2;
3. Diagnosis of definite, probable or possible HeFH based either on clinical criteria (Simon Broome register criteria or Dutch Lipid Clinics [DLC] Network Criteria) or genotyping and at the defined eligibility visit (screening or post washout/stabilization)
4. LDL-C ≥70 mg/dL (if very-high risk for CVD) or ≥100 mg/dL (if high risk for CVD) and TG ≤400 mg/dL while on stable lipid lowering oral drug therapy (eg, maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and less frequently than daily as long as the dose and dosing frequency is consistent.
5.Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, and unable to tolerate any other allowed oral lipid lowering agent, and thus on no lipid lowering therapy must have an LDL-C ≥190 mg/dL (4.9 mmol/L) at the Screening Visit unless they have a documented pathogenic FH variant; 
 
ExclusionCriteria 
Details  1. Use of prohibited oral lipid lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of the Screening Visit or LDL/plasma apheresis within 2 months prior to Day 1;
2. Documented history of HoFH defined clinically or genetically
3. History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator.
4.Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;
5. Moderate to severe renal dysfunction, defined as an eGFR <30 mL/min/1.73m2 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline compared to placebo in LDL-C level  24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities
Incidence of Treatment-Emergent Adverse Events (TEAE) as assessed by Medical Dictionary for Regulatory Activities as mild, moderate or severe compared to placebo
Change in serum free PCSK9 with LIB003 compared to placebo
Change in percent LS mean between LIB003 and placebo 		 24 weeks 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="100" 
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)   01/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/05/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
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   This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with Heterozygous FH on stable diet and oral LDL-C lowering drug therapy 
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