FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099562 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Dapagliflozin and Saroglitazar in Metabolic dysfunction associated steatotic liver disease. 
Scientific Title of Study   Efficacy and Safety of Dapagliflozin compared to Saroglitazar in patients with Metabolic dysfunction associated steatotic liver disease (MASLD): A non-inferiority, randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishi 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Pharmacology, Indira Gandhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone  9315751930  
Fax    
Email  nishi91mbbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalit Mohan 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Pharmacology, Indira Gandhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone  8210052521  
Fax    
Email  drlalitjee@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishi 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Pharmacology, Indira Gandhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone  9315751930  
Fax    
Email  nishi91mbbs@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Patna 
 
Primary Sponsor  
Name  No sponsor 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 Nishi  Indira Gandhi Institute of Medical Sciences, Patna  Department of Gastroenterology, OPD Room no 23
Patna
BIHAR 		 9315751930

nishi91mbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Dapagliflozin  Tab Dapagliflozin 10mg Once a day for 6 months 
Comparator Agent  Saroglitazar  Tab Saroglitazar 4mg Once a day for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A.Evidence of Hepatic Steatosis Confirmed through imaging techniques (such as ultrasound, CT, MRI) or histology (biopsy)
and
presence of at least 1 out of 5 Cardiometabolic Risk Factor.

Cardiometabolic risk factors include-
1.Overweight/Obesity: BMI more than and equal to 25 kg/m² (more than and equal to 23 kg/m² for Asian populations), or waist circumference more than 94 cm (men) or more than 80 cm (women), with ethnicity-adjusted thresholds where applicable
2.Impaired Glucose Metabolism: Fasting glucose more than and equal to 100 mg/dL (5.6 mmol/L), 2-hour post-load glucose more than and equal to 140 mg/dL (7.8 mmol/L), HbA1c more than and equal to 5.7percent, or diagnosed type 2 diabetes mellitus (or its treatment)
3.Hypertension: Blood pressure more than and equal to 130/85 mmHg, or ongoing antihypertensive therapy
4.Hypertriglyceridemia: Triglycerides more than and equal to 150 mg/dL (1.70 mmol/L) or use of lipid-lowering therapy
5.Low HDL Cholesterol: HDL less than and equal to 40 mg/dL (men) or less than and equal to 50 mg/dL (women), or on lipid-lowering treatment

B.Patient’s willingness to comply with the study protocol and prior written informed consent
 
 
ExclusionCriteria 
Details  i) Patients with alternate causes of fatty liver including:-
a) Patients on TPN and those who underwent surgical procedures within 90 days from randomization
b) presence of other chronic liver disease such as hepatitis B or C, liver cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver
c) use of following drugs for more than 3 months over past 1 year before visit 1 including: Amiodarone, Tamoxifen, Methotrexate, Systemic glucocorticoids, Anabolic steroids, Tetracycline, Estrogen, Vitamin A, Asparagine, Valproate, Chloroquine, ARVs

ii) Use of drugs with potential effect on MASLD such as: Ursodeoxycholic acid, S- Adenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1

iii) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism

iv) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease, heart failure

v) Participant with body weight of more than 30kg/m2

vi)Participation in other MASLD/MASH related study within last 3 months

vii) Pregnant or lactating females or couples planning pregnancy within 3 months
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Change in serum ALT levels from baseline to 24 weeks in MASLD patients receiving dapagliflozin 10 mg once daily or saroglitazar 4 mg once daily.  Change in serum ALT levels from baseline to 24 weeks in MASLD patients receiving dapagliflozin 10 mg once daily or saroglitazar 4 mg once daily. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in CAP and LSM values (on FibroScan).  At 12 and 24 weeks 
Change in FIB-4 score  At 12 and 24 weeks 
Change in hepatic steatosis index.  At 12 and 24 weeks 
Change in AST:Platelet index.  At 12 and 24 weeks 
Change in blood pressure  At 12 and 24 weeks 
Change in serum lipid profile.  At 12 and 24 weeks 
Change in glucose metabolic parameters (HbA1c, fasting plasma glucose, HOMA-IR).  At 12 and 24 weeks 
Change in anthropometric parameters (body weight, BMI, waist/hip ratio).  At 4, 12 and 24 weeks 
Change in quality of life scores assessed by the Short-Form 36 Health Survey.  At 24 weeks 
Safety and tolerability   At 24 weeks 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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)   19/01/2026 
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="2"
Months="0"
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   MASLD is an increasingly prevalent chronic liver condition associated with insulin resistance, dyslipidemia and obesity. There are currently no FDA approved pharmacological therapies for MASLD. Saroglitazar, a dual PPAR alpha gamma agonist, has shown beneficial effects on liver fat, glycemic control and lipid parameters in MASLD and NASH in Indian studies. Similarly, dapagliflozin has shown improvements in liver fat, body weight and metabolic parameters in patients with type 2 diabetes and MASLD. Direct comparative evidence between these two agents is limited. This randomized non inferiority study aims to compare the efficacy and safety of dapagliflozin 10 mg once daily and saroglitazar 4 mg once daily over 24 weeks in patients with MASLD. The study will assess changes in liver enzymes, non invasive fibrosis and steatosis indices, metabolic and anthropometric parameters, lipid and glucose profiles, blood pressure and quality of life. 
Close