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CTRI Number  CTRI/2024/10/075998 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the safety and effectiveness of a cholesterol-lowering injection of Inclisiran Sodium in Indian patients with high cholesterol or mixed lipid disorders. 
Scientific Title of Study   A real-world, prospective, multi-center, open-label, phase 4 clinical study to evaluate the safety and effectiveness of subcutaneous injection of inclisiran sodium in Indian patients with primary hypercholesterolemia or mixed dyslipidemia 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Protocol Number CKJX839A1IN03 Version 00 dated 25-Oct-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pallavi Kawatra 
Designation  Franchise Medical Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 7th floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  8971676653  
Fax    
Email  pallavi.kawatra@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Pallavi Kawatra 
Designation  Franchise Medical Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 7th floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  8971676653  
Fax    
Email  pallavi.kawatra@novartis.com  
 
Details of Contact Person
Public Query  
Name  Pallavi Kawatra 
Designation  Franchise Medical Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 7th floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  8971676653  
Fax    
Email  pallavi.kawatra@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland  
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd  
Address  7th floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai – 400051, India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gouranga Sarkar  IPGME&R SSKM Hospital  Department of Cardiology, IPGME&R and SSKM Hospital, 244, A. J. C. Bose Road, Kolkata, West Bengal, India- 700020
Kolkata
WEST BENGAL 		 8910236595

drgourangastudy@gmail.com 
Dr Arijit kumar Ghosh  All India Institute of Medical Sciences  Department of Cardiology, All India Institute of Medical Sciences, Plot no. 02, Sector-20, MIHAN, Nagpur, Maharashtra- 441108, India
Nagpur
MAHARASHTRA 		 8007658278

akumarg@aiimsnagpur.edu.in 
Dr Sandeep Seth  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Room No. 02, 7th floor, CNC Building, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Delhi, India -110029
New Delhi
DELHI 		 9650929005

drsandeepseth@hotmail.com 
Dr Satyajit Singh  All India Institute of Medical Sciences  All India Institute of Medical Sciences,Great Eastern Road, Tatibandh, Raipur 492099
Raipur
CHHATTISGARH 		 7008430223

dr_satyajit_4778@yahoo.co.in 
Dr Viji Thomson  Christian Medical College and Hospital  Christian Medical College and Hospital, Vellore, Kilminnal, Ranipet Campus, 632517.
Vellore
TAMIL NADU 		 8903202227

vijisamuel.t@cmcvellore.ac.in 
Dr Prasad MR  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre Nehru Nagar, Belagavi, Karnataka- 590010, India
Belgaum
KARNATAKA 		 9243245777

drprasadmr@gmail.com 
Dr Sanjaykumar Sharma  Maharaja Agrasen Superspeciality Hospital  "Maharaja Agrasen Superspeciality Hospital, Central Spine, Sector-7, Agrasen Aspatal Marg, Vidyadhar Nagar, Jaipur, Rajasthan, India- 302039 "
Jaipur
RAJASTHAN 		 9461011234

sanjaysharma.clinical@gmail.com 
Dr Selvamani Sethuraman  Meenakshi Mission Hospital & Research center  Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Road, Madurai-625107, Tamil Nadu, India
Madurai
TAMIL NADU 		 9842158868

maniselvacardio@gmail.com 
Dr Bagirath Raghuraman  Narayana Institute of Cardiac Sciences-Narayana hrudayalaya Limited  Narayana Institute of cardiac Sciences, Narayana Hrudayalya Limited ,258/A Bommasandra industrial Area, Hosur Road, Bangalore, Karnataka,560099
Bangalore
KARNATAKA 		 9845144830

bagirath.raghuraman.dr@narayanahealth.org 
Dr Dhiraj Kumar  Seth G. S. Medical College and KEM Hospital  Seth GS Medical College and K.E.M. Hospital, CVTC Building, Department of Cardiology, Acharya Donde Marg, Parel Mumbai-400012, Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA 		 9323361116

dhiraj1645@gmail.com 
Dr Lachikarathman D  Shri Jayadeva Institute of Cardiovacular Sciences & Research  Bannerghatta Road, Jayanagar, 9th Block, Bangalore- 560069
Bangalore
KARNATAKA 		 9886914428

lachikarathmand@yahoo.com 
Dr Sandeep Bansal  Vardhman Mahavir Medical College & Safdarjung Hospital  Roon No 754, 7th floor, Clinical Research Room, Super Specialty Building, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi – 110029
New Delhi
DELHI 		 9810543368

drsbansal2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
IEC, Maharaja Agrasen Hospital  Approved 
Institute Ethics Committee All India Institute Of Medical Sciences  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee for Clinical Trial, All India Institute of Medical Sciences, Nagpur  Approved 
Institutional Ethics Committee IEC-I  Approved 
Institutional Ethics Committee of KLE Academy of Higher Education and Research  Approved 
Institutional Ethics Committee, Meenakshi Mission Hospital & Research Centre  Approved 
Institutional Ethics Committee, Vardhman Mahavir Medical College & Safdarjung Hospital  Submittted/Under Review 
Institutional Review Board, Christian Medical College  Approved 
IPGME and R Research and Oversight Committee, IPGME&R SSKM Hospital  Approved 
Narayana Health Medical Ethics Committee,Narayana health City  Approved 
Shri Jayadeva Institute of Cardiovacular Sciences & Research, Bannerghatta Road, Jayanagar, 9th Block, Bangalore- 560069  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E780||Pure hypercholesterolemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inclisiran SC injection  A real-world, prospective, multi-center, open-label, phase 4 clinical study to evaluate the safety and effectiveness of subcutaneous injection of inclisiran sodium in Indian patients with primary hypercholesterolemia or mixed dyslipidemia. Dose and frequency: The recommended dose of inclisiran sodium per India PI and EMA Summary of Product Characteristics (Leqvio Summary of Product Characteristics) is 300 mg (equivalent to 284 mg inclisiran) administered as a single SC injection: initially on Day 1, at 3 months (Day 90), and every 6 months thereafter. Route of Administration: Subcutaneous. Duration of treatment: The planned duration of treatment is 270 days with 3 single doses of inclisiran sodium, on each Day 1, Day 90, and Day 270 (EOT) followed by a safety follow-up on Day 300 (EOS) after the last dose of the study treatment 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Participants eligible for inclusion sodium in this study must meet all of the following criteria:
1. Signed informed consent must be obtained prior to participation in the study.
2. Male and female Indian participants aged ≥18 years or older.
3. Participants for whom the treating physician prescribes treatment with inclisiran sodium in
adherence with the India Prescribing Information (PI) i.e., patients who are diagnosed with
primary hypercholesterolemia (heterozygous familial and non-familial) or mixed
dyslipidemia, as an adjunct to diet:
a. in combination with a statin or statin with other LLTs in patients unable to reach
LDL-C goals with the maximum tolerated dose of a statin, or
b. alone or in combination with other LLTs in patients who are statin-intolerant, or for
whom a statin is contraindicated.
4. Participants on LLTs should be on a stable dose for ≥30 days before the first dose
administration of the study treatment. 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria are not eligible for inclusion in this study:
1. Any surgical and/or medical condition, which in the opinion of the treating physician, may
place the participant at higher risk of his/her participation in the study, or is likely to prevent
the participant from complying with the requirements of the study or completing the study.
2. Participants who have previous exposure to inclisiran sodium.
3. Pregnant or nursing (lactating) women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of the study is the incidence and characteristics of TEAEs during the 10
month (300-day) study period with inclisiran sodium. 		 Baseline to day 300 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objectives of the study are:
ï‚· To evaluate the effectiveness of inclisiran sodium in terms of change in LDL-C levels from
baseline to Day 300.
ï‚· To determine the proportion of participants achieving LDL-C goals on Day 300.
ï‚· To evaluate the effectiveness of inclisiran sodium in reducing other lipid markers from
baseline to Day 300. 		 Baseline to day 300  
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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 4 
Date of First Enrollment (India)   20/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The purpose of this study is to evaluate the post-marketing safety and effectiveness of inclisiran
sodium SC injections in Indian patients with a diagnosis of primary hypercholesterolemia
(heterozygous familial and non-familial) or mixed dyslipidemia receiving a statin or statin with
other LLTs and are either unable to reach LDL-C goals with the maximum tolerated dose of a
statin, or are statin-intolerant, or for whom a statin is contraindicated.
ï‚· The study duration will be of 300 days. The total study duration may vary depending on the
visit windows allowed for the treatment period and EOS visit.
ï‚· The treatment duration will be up to Day 270.
ï‚· There will be a total of 4 site visits for each participant.
 
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