Comparison of the two drugs named Saroglitazaar Magnesium 4mg and Ursodeoxycholic acid for their effects on the liver fat and fibrosis in persons having diabetes and fatty liver

A Multicentric, prospective, open-label clinical trial to assess the efficacy and safety of Saroglitazaar Magnesium 4mg along with the standard of care, in the treatment of hepatic steatosis and fibrosis, in comparison to Ursodeoxycholic acid along with standard of care, in people living with Type 2 Diabetes Mellitus and/or Metabolic dysfunction-associated steatotic liver disease. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100723

Enrollment

100

Registered

2026-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Saroglitazar Magnesium 4mg: It is an 4mg oral tablet given , once daily before dinner, and will be given for 6 months Control Intervention1: Ursodeoxycholic acid: This is also an oral t

Eligibility

Inclusion criteria

Inclusion criteria: People having Type 2 Diabetes Mellitus and /or at least one of the four parameters of Metabolic Syndrome: Hypertension ( or taking any drugs for hypertension ), obesity, high triglyceride ( or taking any medications for dyslipidemia), and low HDL. A diagnosis of liver steatosis stage 3 (S3) and/or fibrosis ( F2F3F4) established by Vibration Controoled Transient Elastography using Fibroscan

Exclusion criteria

Exclusion criteria: 1. Having an established diagnosis of Cirrhosis 2. Person with T1DM 3. Person with greater than S3 steatosis if LSM is greater than 8kPa on VCTE 4. Person already on Thiazolidinediones, Vitamin E 5. A person taking alcohol in a quantity more than the standard limits set by AASLD (Asia Pacific region) 6. Person having positive HBsAg or anti-HCV 7. People on steatogenic drugs like amiodarone. Methotrexate, oral contraceptives, and steroids 8. People with other causes of liver disease, e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease 9. Pregnant and lactating females 10. People with underlying diseases like acute viral hepatitis. congestive hepatomegaly, or biliary congestion, can disturb the estimation done by VCTE 11. Person having Hepatocellular Carcinoma 12. Person having a known allergy to saroglitazar 13. A person having any other severe illness that may render the follow-up difficult 14. Person not giving written consent for the study

Design outcomes

Primary

Measure	Time frame
The primary objective of the proposed study is to evaluate the efficacy of Saroglitazaar magnesium 4mg along with standard of care (SOC) on hepatic steatosis and fibrosis in comparison to ursodeoxycholic acid along with SOC in people living with T2DM and Metabolic dysfunction-associated steatotic liver disease (MASLD)Timepoint: The participants will be assessed at baseline, then at 4 weeks, 12 weeks and finally at 24 weeks	—

Measure

Time frame

The primary objective of the proposed study is to evaluate the efficacy of Saroglitazaar magnesium 4mg along with standard of care (SOC) on hepatic steatosis and fibrosis in comparison to ursodeoxycholic acid along with SOC in people living with T2DM and Metabolic dysfunction-associated steatotic liver disease (MASLD)Timepoint: The participants will be assessed at baseline, then at 4 weeks, 12 weeks and finally at 24 weeks

—

Secondary

Measure	Time frame
To evaluate the efficacy of saroglitazaar magnesium 4mg on blood glucose levels,blood lipid levels, liver function tests, compared to ursodeoxycholic acidTimepoint: The participants will be assessed at baseline, 4 weeks, 12 weeks, & finally at 24 weeks	—

Countries

India

Contacts

Public ContactDINESH KUMAR

Harsha Clinic and Diabetes Centre

dineshharshaclinic@gmail.com9839007147

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026