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CTRI Number  CTRI/2025/04/085418 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effect of Saroglitazar on in NAFLD.  
Scientific Title of Study   To assess the Effect of Saroglitazar on Fatty Liver Index and Fibroscan parameters [Linear Shear Measurement (LSM) and Controlled Attenuation Parameters (CAP)] in patients of Non Alcoholic Fatty Liver Disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Goyal 
Designation  Professor  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  H No 44/9J Medical Campus PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9968969651  
Fax    
Email  sandeepgoyal20000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Goyal 
Designation  Professor  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  H No 44/9J Medical Campus PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9968969651  
Fax    
Email  sandeepgoyal20000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sandeep Goyal 
Designation  Professor  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  H No 44/9J Medical Campus PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9968969651  
Fax    
Email  sandeepgoyal20000@gmail.com  
 
Source of Monetary or Material Support  
PT B. D. SHARMA PGIMS HOSPITAL ,ROHTAK 
 
Primary Sponsor  
Name  PT B D SHARMA PGIMS  
Address  ROHTAK,HARYANA,124001 
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 
Dr Sandeep goyal  Pt B.D.SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCES   Pt B D Sharma PGIMS, Daryao nagarROHTAK HARYANA 124001
Rohtak
HARYANA 		 9968969651

Sandeep2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOMEDICAL RESEARCH ETHICS COMMITTE,PGIMS /UHS , ROHTAK,HARYANA  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 
Intervention  DRUG SAROGLITAZAR  Effect of Saroglitazar on Fatty liver index parameters and Fibroscan parameters [LSM(Linear shear measurement) and CAP(Controlled Attenuated Parameter 
Intervention  Drug Saroglitazar   Peroxismal proliferator receptor agonists of alpha and gamma receptors indicated in NAFLD, Diabetic dyslipidemia 
Comparator Agent  NOT APPLICABLE  SINGLE ARM STUDY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  18–65 years diagnosed of NAFLD 
 
ExclusionCriteria 
Details  1.patient with cirrhosis
2. significant alcohol intake
3.use of thiazolidinediones
4.use of drugs causing hepatic fibrosis (amiodarone ,anabolic steroids ,chloroquine,estrogens,high dose vitamin a ,ocp , systemic glucocorticosteroids )
5. liver diseases due to oter etiologies like autoimmune liver disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Saroglitazar on Fatty liver index parameters and Fibroscan parameters [LSM(Linear shear measurement) and CAP(Controlled Attenuated Parameter )] in Patients of Non Alcoholic Fatty liver Disease  Assessed at 0 and 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Saroglitazar on Fatty liver index parameters and Fibroscan parameters [LSM(Linear shear measurement) and CAP(Controlled Attenuated Parameter )] in Patients of Non Alcoholic Fatty liver Disease  3 MONTHS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 4 
Date of First Enrollment (India)   07/05/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Nonalcoholic fatty liver disease (NAFLD) involves fat accumulation in the liver (hepatic steatosis) without significant alcohol consumption or secondary causes. It is a common chronic liver disease, affecting approximately 25-30% of the global population, and can progress to more severe forms like non-alcoholic steatohepatitis (NASH). NASH can lead to fibrosis, cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC), marking it as a significant cause for liver transplantation.

Pathophysiology: NAFLD’s progression is associated with insulin resistance and various cellular changes, including oxidative stress, inflammation, and hepatocyte damage. Key proinflammatory cytokines like TNF-α, MCP-1, and IL-6 contribute to the disease process, driving the progression from NAFL to NASH and inducing hepatic inflammation and fibrosis.

Symptoms: Many patients are asymptomatic; however, some may report fatigue, right upper quadrant discomfort, or hepatomegaly. Signs of chronic liver disease are rare at diagnosis.

Treatment Options: While only Pioglitazone and vitamin E are approved for treating NAFLD/NASH, Saroglitazar, a dual PPAR-α and PPAR-γ agonist, has been recently approved for treating NAFLD in India. Saroglitazar enhances lipid oxidation and insulin sensitivity, reducing lipotoxicity and showing positive effects in clinical trials, such as improvements in hepatic steatosis, inflammation, and metabolic parameters.

Clinical Studies: Recent studies illustrate Saroglitazar’s efficacy in reducing liver enzymes (ALT, AST), liver stiffness (measured by FibroScan), and improving lipid profiles in NAFLD patients. Various trials report significant reductions in hepatic fat content, transaminases, and improvements in biochemical markers across different populations, including those with and without diabetes.

Research Focus: The proposed study aims to assess the effects of Saroglitazar on fatty liver index parameters and FibroScan results in patients diagnosed with NAFLD. This will involve a prospective observational design assessing biochemical, histological, and FibroScan parameters at baseline and after 3 and 6 months of treatment.

Objectives:

  • Assess the impact of Saroglitazar on liver fibrosis and steatosis.
  • Evaluate changes in liver function and lipid profiles in patients with NAFLD.

Methodology:

Patients aged 18-65 with diagnosed NAFLD will undergo baseline evaluations, including liver function tests, lipid profiles, ultrasounds, and FibroScan. Saroglitazar (4 mg) will be administered daily for three months, with follow-up assessments conducted at three and six months to monitor changes in liver function, lipid profiles, and steatosis severity.

This comprehensive approach would contribute to evaluating Saroglitazar’s therapeutic potential, paving the way for more effective treatment strategies for NAFLD.


 
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