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CTRI Number  CTRI/2022/09/046081 [Registered on: 30/09/2022] Trial Registered Prospectively
Last Modified On: 28/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to assess the benefits and safety profile of the drug Saroglitazar in patients of non alcoholic fatty liver disease who are not obese(BMI less than 25) 
Scientific Title of Study   SAFETY AND EFFICACY OF SAROGLITAZAR IN PATIENTS WITH NON-OBESE NAFLD: OPEN LABEL RANDOMISED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arka De 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Liver Office, Dept. of Hepatology, NHEB, PGIMER, Chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9999816539  
Fax    
Email  arkascore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arka De 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Liver Office, Dept. of Hepatology, NHEB, PGIMER, Chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9999816539  
Fax    
Email  arkascore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Naveen Bhagat 
Designation  Senior resident 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Liver Office, Dept. of Hepatology, NHEB, PGIMER, Chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9697512683  
Fax    
Email  naveendandia@gmail.com  
 
Source of Monetary or Material Support  
DEPT OF HEPATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH 
 
Primary Sponsor  
Name  PGIMER CHANDIGARH 
Address  Dept of Hepatology, NEHRU EXTENSION BLOCK PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arka De  Dept of Hepatology, PGIMER, Chandigarh  Dept of Hepatology, NHEB, PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH 		 9999816539

arkascore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saroglitazar  Saroglitazar (4 mg/day) along with standard medical therapy for 6-months 
Comparator Agent  Standard medical therapy  Standard medical therapy consisting of lifestyle interventions and other supportive therapy for 6-months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with normal BMI (>18 to < 25 kg/m2) diagnosed as NAFLD defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol (<20g/day) irrespective of gender after ruling out other etiologies of other etiologies for hepatic steatosis or elevated transaminases including but not limited to chronic viral hepatitis, autoimmune Hepatitis, hemochromatosis, Wilson disease, celiac disease, drug induced liver injury (DILI), etc. and having LSM <13.6 kPa 
 
ExclusionCriteria 
Details  Patients with BMI ≥ 25 kg/m2, age <18 years or >75 years of age.
Patients with cirrhosis or with HCC or any other malignancy.
Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases. Patients already on Vitamin E or pioglitazone.
Pregnant or lactating.
Patients too sick or not consenting to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in hepatic steatosis as evidenced by CAP at 6 months  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in steatohepatitis as evidenced by FibroScan-AST score (FAST) score at 6 months
2. Improvement in hepatic fibrosis at 6 months by non-invasive parameters [Liver stiffness measurement(LSM), AST to Platelet Ratio (APRI), FIB4]
3. Improvement in ALT (in those with baseline elevated ALT)
4. Change in glycemic profile at 6 months by HbA1c
5. Change in Lipid profile
6. Adverse effects of saroglitazar using CTCAE version 5
7. Change in anthropometric parameters[Body weight, Body Mass Index(BMI) and abdominal circumference]
8. Change in insulin resistance as assessed by HOMA – IR
9. Improvement in the Quality of life assessed through CLDQ Questionnaire 		 6 months 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   N/A 
Date of First Enrollment (India)   03/10/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arkascore@gmail.com].

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 15-01-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

NAFLD has emerged as one of the commonest causes of chronic liver disease globally with a global prevalence of around 25%. In India, the prevalence of NAFLD is 9 to 53% with a possible rural/urban and geographic divide. There is an intricate bidirectional relationship between metabolic comorbidities and NAFLD. As the number of comorbidities increases, the risk of having NAFLD increases and also patient with NAFLD are at a higher risk of having metabolic risk factors. Obesity is the most important risk factor for the development of NAFLD, however one of the intriguing observation is that some patients are non-obese defined by body mass index (BMI <25 kg/m2)  in the absence of “significant” alcohol intake.5 This phenotype which was first described in Indians and Chinese has now been recognized worldwide and it is estimated that 20-30 % patients are non-obese. 

The management of non-obese NAFLD patient is a clinical conundrum. The standard of care in patients of the classical phenotype is lifestyle interventions with a target to achieve a weight loss of 7 to 10% over 6 months. However, since many patients with non-obese NAFLD already have a normal body weight, this is not a feasible target option in such patients. Based on the landmark PIVENS trial, Vitamin E and pioglitazone has been recommended by international authorities for the treatment of biopsy proven Non-Alcoholic steato-hepatitis(NASH), although it is not approved for the same. Recently, on the basis of real world data and EVIDENCES II and IV data, drug controller general of India has approved saroglitazar for the treatment of NAFLD with F1 to F3 fibrosis, NAFLD with metabolic comorbidities and biopsy proven NASH. However, the role of pharmacotherapy in patients with non-obese NAFLD per se has never been evaluated. Hence, we aim to study the safety and efficacy of saroglitazar in patients with lean NAFLD in an open labelled trial.

 
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