CTRI

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CTRI Number

CTRI/2025/03/083565 [Registered on: 27/03/2025] Trial Registered Prospectively

Last Modified On:

31/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

Efficacy of Saroglitazar in patients with Fatty Liver

Scientific Title of Study

Efficacy of Saroglitazar in patients with Metabolic Dysfunction Associated Steatotic Liver Disease With Associated Etiology of Steatotic 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	Siddharth Sharma
Designation	Senior resident
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh Chandigarh CHANDIGARH 160036 India
Phone	8168146664
Fax
Email	htrahddis0013@gmail.com

Details of Contact Person
Scientific Query

Name	Ajay Duseja
Designation	Professor
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh Chandigarh CHANDIGARH 160036 India
Phone	8168146664
Fax
Email	ajayduseja@yahoo.co.in

Details of Contact Person
Public Query

Name	SIDDHARTH SHARMA
Designation	SENIOR RESIDENT
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Postgraduate Institute of Medical Education and Research, Sector 12, Madhya Marg, Chandigarh Madhya Marg, Sector 12, Chandigarh Chandigarh CHANDIGARH 136135 India
Phone	8168146664
Fax
Email	htrahddis0013@gmail.com

Source of Monetary or Material Support

Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate Institute of Medical Education and Research, Sector 12, Madhya Marg, Chandigarh

Primary Sponsor

Name	Department of Hepatology Postgraduate institute of medical education and research
Address	Department of Hepatology Room no. 36 Nehru Hospital Extension Postgraduate Institute of Medical Education and Research, Sector 12, Madhya Marg, 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
SIDDHARTH SHARMA	Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh	Department of Hepatology , Room no. 36, Nehru Hospital Extension. Postgraduate institute of medical education and research, Sector 12, Madhya Marg, Chandigarh Chandigarh CHANDIGARH	8168146664 htrahddis0013@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE(INTRAMURAL), POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH	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
Comparator Agent	Saroglitazar	Saroglitazar in patients with MASLD with other associated etiologies. Saroglitazar will be given in the dose of 4 mg per oral daily for 6 months
Intervention	Saroglitazar	Saroglitazar was given to patients with pure MASLD patients in the dose of 4mg daily per oral for 6 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using controlled attenuation parameters (CAP) (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria . 2.Patients of MASLD with moderate amount of alcohol intake (Met ALD) 3.Patients of MASLD with hepatitis C infection 4.Patients of MASLD with HBV infection 5.Patients of MASLD taking one of the steatogenic drugs 6. Patients in all above categories having with liver stiffness measurement (LSM) on VCTE (Fibroscan) of more than 8kPa and less than 13.6 kPa

ExclusionCriteria

Details

1. Patients of compensated or decompensated cirrhosis

2. Patients with HCC or any other malignancy

3. Patients already on Vitamin E, Saroglitazar or pioglitazone

4. Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study.
5. Patients who are too sick to conduct the protocol.

6. Patients with significant ethanol intake (more than 60 g/ day and 50g/day in males and females respectively)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD with/without associated etiology	Assessment will be done at baseline, 3 months and 6 months

Secondary Outcome

Outcome

TimePoints

Comparison of improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD and MASLD with associated etiology of SLD
Improvement in fibrosis as evidenced by LSM, APRI, FIB-4, AGILE-3+, AGILE 4 at 6 months in MASLD with associated etiology
Improvement in steatosis as evidenced by MRI PDFF and MRE at 6 months
Improvement in steatohepatitis as evidenced by FibroScan-AST score (FAST) and MAST score at 6 months
Improvement in hepatic fibrosis at 6 months by non-invasive parameters [Liver stiffness measurement (LSM).
Improvement in ALT (in those with baseline elevated ALT)

6 months

Target Sample Size

Total Sample Size="88"
Sample Size from India="88"
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 4

Date of First Enrollment (India)

07/04/2025

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="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Yet Recruiting

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

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

Saroglitazar may have beneficial role in NAFLD with significant fibrosis. No studies have analyzed the role of saroglitazar in MASLD with associated etiology . We will conduct this study in order to study efficacy of saroglitazar in patients with Met ALD and MASLD with associated etiologies. Treatment response will be compared between MASLD and MASLD with associated etiologies. We will compare with response of saroglitazar in patients with pure MASLD and multiple etiology SLD. We will also assess the role of saroglitazar in improvement of fibrosis and steatosis in patients with MASLD with associated etiology.