Comparison of Pioglitazone vs Saroglitazar in patients suffering from fatty liver disease

Comparative Study of Efficacy of Pioglitazone vs Saroglitazar in Patients of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) with Diabetes : A Prospective Randomised Interventional Study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/107139

Enrollment

120

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Saroglitazar: 4 mg one tablet orally once daily after breakfast for 52 weeks. Control Intervention1: Pioglitazone: 30 mg one tablet orally once daily after breakfast for 52 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic patients with CAP score more than 262 dB/m.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Change in VCTE measured LSM between the patients receiving pioglitazone and saroglitazar.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) and 1 year (52 weeks).	—

Secondary

Measure	Time frame
Change in VCTE measured CAP between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).;Change in AST & ALT between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).;Change in body fat percentage & visceral fat analysis between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).	—

Measure

Time frame

Change in VCTE measured CAP between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).;Change in AST & ALT between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).;Change in body fat percentage & visceral fat analysis between patients receiving saroglitazar & pioglitazone.Timepoint: Measured at baseline (0 weeks), 6 months (24 weeks) & 1 year (52 weeks).

—

Countries

India

Contacts

Public ContactPrithvijit Kole

Nil Ratan Sircar Medical College and Hospital.

dr.soumikgoswami@gmail.com9903950841

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026