CTRI/2023/05/053326 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On:
17/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
A study to evaluate the safety and effectiveness of Saroglitazar 4 mg in patients with NAFLD with comorbidities
Scientific Title of Study
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
SARO.21.003,Version 5 dated 12 November 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr. Bhargav Darji
Designation
Sr.Manager
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre,
Survey No. 396/403,
Sarkhej-Bavla National Highway No.8A Moraiya,
D Block, 3rd Floor, Galaxy Bazar, Sunrise Park Road, Vastrapur, Ahmedabad, 380054 Ahmadabad GUJARAT
919276558517
ravindragaadhe@gmail.com
Dr Shanid A
Government Medical College, Thiruvananthapuram
Department of Medical Gastroenterology, Superspeciality block, Government Medical College, Thiruvananthapuram, 695011, Kerala, India
Thiruvananthapuram KERALA
9447106999
drshanid@gmail.com
Dr Souveek Mitra
Indian Institute of Liver and Digestive Sciences
Sitala East, Sonarpur, Kolkata- 700150
Kolkata WEST BENGAL
9903890342
souveek84@gmail.com
Dr Rakhi Maiwall
Institute of Liver & Biliary Sciences
D1, Vasant Kunj Road, Ghitorni, New Delhi, Delhi-110070.
New Delhi DELHI
8750343085
rakhi_2011@yahoo.co.in
Dr Rajib Sarkar
Institute of Postgraduate Medical Education & Research (IPGMER&R) and SSKM Hospita
"BAPS Pramukh Swami Hospital Institutional Ethics Committee Shri Swami Maharaj Marg, Adajan Char Rasta Surat - 395009 "
Approved
"Clinical Research Ethics Committee Medica Superspecialty Hospital ,127, Mukundapur E. M. Bypass Kolkata (India) - 700099 India"
Approved
"Drug Trial Ethics Committee Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana Punjab - 141001 India "
Approved
"ETHICS COMMITTEE GMC and GGH Guntur Medical College Kannavari Thota Main Road Guntur Guntur Andhra Pradesh - 522004 India"
Approved
"Gastroplus Ethics Committee D Block, 3rd Floor, Galaxy Bazar, Sunrise Park Road, Vastrapur, Ahmedabad, 380054 "
Approved
"Human Research Ethics Committee, IILDS Indian Institute Of Liver And Digestive Sciences Sitala East, Malipukuria Jagadishpur Sonarpur South 24 Parganas West Bengal - 700150 India"
Approved
"IEC Fortis Hospital Mohali Sector - 62 Phase VIII Mohali SAS Nagar Punjab - 160062 India"
"Institutional Ethics Committee BGS Global Hospitals BGS Health and Education City 67, Uttarahalli Main Road Kengeri Bengaluru (Bangalore) Urban Karnataka - 560060 India"
Approved
"Institutional Ethics Committee Deep Hospital Deep Hospital Deep Hospital 481, Model Town Ludhiana, Punjab - 141002 India "
Approved
"Institutional Ethics Committee Institute of Liver and Biliary Sciences D-1 Vasant Kunj New Delhi South Delhi Delhi - 110070 India"
Approved
"INSTITUTIONAL ETHICS COMMITTEE Kurnool Medical College/Government General Hospital Budhawarpet, Kurnool Andhra Pradesh - 518002 India"
"Institutional Ethics Committee Osmania Medical College,Koti, Hyderabad,Telangana-500095 "
Approved
"Institutional Ethics Committee TNMC NAIR HOSPITAL Topiwala National Medical College Nair Hospital Dr A L Nair Road Mumbai Central Mumbai City Maharashtra - 400008 India"
Approved
"Institutional Ethics Committee, AIIMS, Bhubaneswar All India Institute of Medical Sciences, BBSR AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha, India – 751019"
"Leelavati Ethics Committee Leelavati Care Hospital Near Big Bazar College Road Nashik Maharashtra - 422005 India "
Approved
"Maharaja Agrasen Hospital Institutional Ethics Committee Maharaja Agrasen Hospital, Punjabi Bagh, New Delhi West Punjabi Bagh West Punjabi Bagh New Delhi West Delhi – 110026, India "
"NHRTIICS Ethics Committee NHRTIICS 124, Mukundapur, E. M. Bypass Kolkata West Bengal - 700099 India"
Approved
"Sahyadri Hospitals Ltd. Ethics committee Sahyadri Clinical Research & Development Center (A Unit of Sahyadri Hospitals Ltd.), 33/34B, Makarand Bhave Path, Karve Road, Pune- 411004, Maharashtra, India"
Approved
"Samvedna Hospital Ethics Committee Samvedna Hospital B-22/88 G New Ravindra Puri Colony Varanasi Varanasi Uttar Pradesh - 221005 India"
"Shrey Hospital Institutional Ethics Committee Shrey Hospital Private Limited 270/B/5 Near AMCO Bank, Stadium Circle Navrangpura Ahmedabad Gujarat - 380009 India"
Approved
"Sir Ganga Ram Hospital Ethics Committee, Sir Gangaram Hospital, Sir Gangaram Hospital Marg, Rajinder Nagar, New Delhi- 110060"
Approved
"Yashoda Academy of Medical Education and Research Yashoda Hospitals Behind Hari Hara kala Bhawan SP Road Secunderabad, Hyderabad Telangana - 500003 India "
Human Ethics Committee Government Medical College, Medical College P O, Thiruvananthapuram, 695011, Kerala, India
Approved
Institutional Ethics Committee, Sir H.N. Reliance Foundation Hospital And Research Center, Prarthana Samaj, Raja Rammohan Roy Rd, Girgaon, Mumbai, Maharashtra, India-400004.
Approved
Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre.Amrita Institute of Medical Sciences and Research Centre, AIMS Ponekkara P.O, Kochi-682041
Approved
Integrity Ethics Committee, CHL-Hospitals CHL-Hospitals, Convenient Hospitals Ltd., Near L. I. G. Square A. B. Road Indore Madhya Pradesh - 452008 India
Approved
IPGMEandR Research Oversight Committee IPGME&R SSKM hospital 244 Acharya J. C. Bose Road – Kolkata West Bengal - 700020 India
Approved
Malla Reddy Medical College for Women Institutional Ethics Committee,Suraram X-Roads, Jeedimetla, Hyderabad-500055
Approved
SR Kalla Memorial Ethics Committee for Human Research
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not Applicable
Not Applicable
Intervention
Saroglitazar
Dose:- 4 mg tablets.
Route:-Oral
Frequency :once daily
Duration:364 days/52 weeks of treatment period
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Male and female patients aged ≥18 years
2. Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
3. Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
4. Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria (Refer Appendix III for diagnostic criteria). NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:
a. Liver stiffness through transient elastography, an LSM ≥8 kPa
OR
b. Serum ALT ≥45 U/L
ExclusionCriteria
Details
1.Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females.
2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
3.Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
4.Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
5.History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
6.Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
8. Pregnant or breast feeding females.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in liver stiffness measurement performed by transient elastography and Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Baseline to Week 52
Secondary Outcome
Outcome
TimePoints
Change in serum ALT value
Baseline to Week 24 and Week 52
Change in serum AST
Baseline to Week 24 and Week 52
Change in serum ALP value
Baseline to Week 24 and Week 52
Change in TG, HDL-C, LDL-C and non HDL-C levels
Baseline to Week 24 and Week 52
Change in body weight and BMI
Baseline to Week 24 and Week 52
To evaluate the safety of Saroglitazar 4 mg once daily in the study population
Baseline to Week 52
Target Sample Size
Total Sample Size="1500" Sample Size from India="1500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a
phase 4, non-randomised, multicentre, open-label study.The study will be
conducted at multiple study centres across India.The study is
planned to enroll approximately 1500 patients. This is Open-label Treatment Phase (364
days/52 weeks) study.