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CTRI Number  CTRI/2019/11/021919 [Registered on: 07/11/2019] Trial Registered Prospectively
Last Modified On: 18/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Test the Use of Cetilistat tablet in over weight individuals 
Scientific Title of Study   A Phase III, Multi-Center, Comparative, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Cetilistat in Adult Obese Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/CETIOBE/10/2015, Version 2.0 dated 02 Nov 2018  Protocol Number 
HCR/III/CETIOBE/10/2015, Version 3.0 dated 07 Mar 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary 
Designation  Deputy General Manager 
Affiliation  Hetero Labs Limited 
Address  CDMA Department, 2nd Floor, Hetero Corporate, 7-2-A2 Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr SD Sinha 
Designation  Sr. Vice President 
Affiliation  Hetero Labs Limited 
Address  CDMA Department, 2nd Floor, Hetero Corporate, 7-2-A2 Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Ltd; 7-2-A2 Industrial Estates, Sanath Nagar; Hyderabad – 500 018, Telengana, India Phone no: 040 23704923  
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  7-2-A2 Industrial Estates, Sanath Nagar; Hyderabad – 500 018, Telengana, India Phone no: 040 23704923  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemant Ramsharan Gupta MD  Grant Govt. Medical College & Sir JJ Hospital  Department of Medicine, OPD 20, Main Building, Byculla, Mumbai-400008
Mumbai
MAHARASHTRA 		 9820095763

drhemantgupta@hotmail.com 
Dr Jitendra Anand MD  Kanoria Hospital & Research Centre  Department of Medicine, Ground floor, room no 2, Near Indira Bridge, Hansol-Gandhi Nagar Highway, Bhat, Gandhinagar
Ahmadabad
GUJARAT 		 9824517101

jkanand09@gmail.com 
Dr Shubash Chander MD DM Gastroenterology  Maharaja Agrasen Super Speciality Hospital  Basement 209, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar
Jaipur
RAJASTHAN 		 9828511073

subhashdoot@gmail.com 
Dr Vijay Pratap Singh MD  Surya Super Speciality Hospital  Department of Medicine, Ground Floor, A unit of G. V. Meditech (P) Ltd., Room no 4, B-38/46 H Raman Niwas Mahmoorganj Varanasi-221010
Varanasi
UTTAR PRADESH 		 9415617681

vps_apollo@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
G. V. Meditech Pvt Ltd.B-38/46 H Raman Niwas Mahmoorganj Varanasi-221010, U. P. India. ECR/14/Inst/UP/2013-RR-16  Approved 
Institutional Ethics Committee Department of Pharmacology, Sir JJ Hospital, Mumbai-400008 ECR/382/MH/INST/RR-2016  Approved 
Institutional Ethics Committee,6th Floor, Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026 ECR/745/Inst/DL/2015/RR-18  Approved 
Kanoria Ethics Committee Hansol-Gandhi Nagar Highway, Bhat, Gandhinagar, Ahmedabad, Gujarat-382428 ECR/620/Inst/GJ/2014/RR-17  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cetilistat 120mg tablet  Cetilistat 120mg tablets and matching placebo of orlistat 120mg capsules three times a day with each main meal (during or up to 1 hour after the meal) for 12 weeks 
Comparator Agent  Orlistat 120mg capsules  Orlistat 120mg capsules and matching placebo of cetilistat 120mg tablets three times a day with each main meal (during or up to 1 hour after the meal) for 12 weeks 
Comparator Agent  Placebo  Matching placebo of orlistat 120mg capsules and matching placebo of cetilistat 120mg tablets three times a day with each main meal (during or up to 1 hour after the meal) for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male or female patients aged of 18-65 years
2. The patient with body mass index (BMI) ≥30 kg/m2
3. Females of childbearing potential who are sexually active must agree to use barrier contraceptives
4. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range
 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to any of the components of the study drugs
2. Patients with significant weight loss in the 3 months prior to screening
3. Patients with history of any serious systemic disease
4. Changes in the dosing of antihyperlipidemic or anti-diabetic drugs within 4 weeks of randomization
5. Patients with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, before 4 weeks of screening
6. Patients with history of anaphylaxis associated with medicinal products
7. History of drug or alcohol abuse within the past 2 years
8. Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization
9. Any other serious disease or condition at screening (or randomization) that would compromise patient safety
10. Patients with the current/past infections such as tuberculosis, hepatitis, herpes and/or patients with immune system disorders like HIV and SLE 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The absolute change in body weight  Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving 5% to 10% weight loss  Week 12 
Change in waist circumference  Week 12 
Change in FPG  Week 12 
Change in LDL  Week 12 
Incidence of gastrointestinal adverse events  All Visits 
 
Target Sample Size   Total Sample Size="237"
Sample Size from India="237" 
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)   09/11/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a phase III, double blind, double dummy, comparative, three-arm, active and placebo-controlled, parallel group, randomized, prospective, multicenter, efficacy and safety study. Adult male and female (18 – 65 years) patients with obesity who will meet all the inclusion criteria and none of the exclusion criteria will be included. Total study duration per patient: 18-20 weeks (maximum), depending on the screening period. 
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