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CTRI Number  CTRI/2022/01/039661 [Registered on: 21/01/2022] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction (LIBerate-CVD) 
Scientific Title of Study   Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-CVD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2020-004392-40  EudraCT 
LIB003-005 v1 21Oct2020 & IND Protocol addendum v1 15Oct2021  Protocol Number 
NCT04797247     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 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
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 Aditya Kapoor  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Cardiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road , Lucknow 226014
Lucknow
UTTAR PRADESH 		 8004904686

akapoor65@gmail.com 
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 Vimal mehta  "G .B. Pant Institute of Postgraduate Medical Education & Research, "  Room No.-133, 1st Floor, Academic Block, Department of Cardiology,
New Delhi
DELHI 		 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 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 ,   Clinical research room, First floor, Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060, India"
New Delhi
DELHI 		 9811057384

drashwanimehta@gmail.com 
Dr Preeti Gupta  Vardhman Mahavir Medical College and Safdarjung Hospital  Room no 725, 7th floor Super Specialty building , 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. Panchamrut Bunglows, Nr. Shukan Mall, Off. Science City Road, Sola, Ahmedabad-380060  Approved 
Institutional Ethics Committee ,Office of the Research Cell, King Georges Medical University Lucknow  Not Applicable 
Institutional Ethics Committee, Room No-306-A, Maulana Azad Medical College, New Delhi-110002, India   Approved 
Institutional Ethics Committee, SGPGI, Lucknow  Not Applicable 
Institutional Ethics Committee- Clinical Studies, Indraprastha Apollo Hospitals, Sarita Vihar, Mathura Road, New Delhi-110076  Approved 
Institutional Ethics Committee; Vardhman Mahavir Medical College and Safdarjung Hospital, Room No. 505 & 506, 5th floor, Main OPD Building, VMMC & Safdarjung Hospital, New Delhi-110029  Approved 
Sir Ganga 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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E780||Pure hypercholesterolemia, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
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. Male or female ≥18 years of age at the first Screening Visit;
3. Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
4. At very high risk for CVD which includes history of CVD, (including cerebrovascular or peripheral arterial disease) or very high risk as defined in the 2019 ESC/EAS Guidelines
5. At Screening or post Washout/Stabilization), ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate;
6. On a stable diet and lipid-lowering oral therapies (such as statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof for at least 4 weeks
7. Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose; 8. Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit;"
 
 
ExclusionCriteria 
Details  "1. Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of screening, LDL or plasma apheresis within 2 months prior to randomization; received other investigational agent(s) such as PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
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
6. Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 × the ULN as determined by central laboratory analysis at screening
7. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism 9. Uncontrolled Type 1 or Type 2 DM, defined as FBS ≥200 mg/dL or HbA1C ≥9%; 10. Uncontrolled serious cardiac arrhythmia, MI, unstable angina, PCI, CABG, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to the Screening Visit; 11. Planned cardiac surgery or revascularization; 12. New York Heart Association class III-IV heart failure"
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
LDL-C change compared to placebo
 		 Week 52
 
 
Secondary Outcome  
Outcome  TimePoints 
"1. Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks
2. Percent change in LS mean from baseline compared to placebo in free PCSK9
3. To assess the effects of LIB003 on the percentage of patients achieving an LDL-C 40 mg/dL, 55 mg/dL, 70 mg/dL, and 100 mg/dL"
 		 1. Week 52
2. Week 52
3. Week 52
 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="50" 
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)  30/04/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy. 
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