Comparing Response to treatment with two different drugs ( Dapagliflozin and Saroglitazaar ) in patients fatty liver and liver fibrosis

A 25-week Multicentric Prospective Open Labelled Trial Comparing the Safety and Efficacy of Saroglitazaar Magnesium 4mg with Dapagliflozin Propanediol Monohydrate 10mg along with Standard of Care in the Treatment of Metabolic Associated Steatotic Liver Disease. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/08/071848

Enrollment

100

Registered

2024-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified

Interventions

Intervention1: Saroglitazaar Magnesium 4mg: Safety and efficacy of Saroglitazaar Magnesium 4mg in the treatment of Metabolic Associated Steatotic Liver Disease for duration of 6 months Control Interve

Eligibility

Inclusion criteria

Inclusion criteria: A diagnosis of MASLD/NAFLD established by Vibration Controlled Transient Elastography using FIBROSCAN. All persons with grade 3 fatty liver and F2 -F4 liver fibrosis on Fibroscan

Exclusion criteria

Exclusion criteria: Persons with known cirrhosis of liver persons with T1DM Persons taking alcohol in quantity more than allowed Persons already taking thiozolidedinediones, Vitamin E and SGLT2 inhibitors. Persons taking alcohol in a quantity more than the standard limits set by aasld (Asia PACIFIC region) Persons having positive HBsAg and anti-HCV Persons with other causes of liver diseases e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease Persons on steatogenic drugs like amiodarone, methotrexate, oral contraceptives, and glucocorticoids. Pregnant and Lactating females Persons having underlying diseases like acute viral hepatitis, congestive hepatomegaly, or billiary congestion which can disturb the estimation done by fibro scan Persons having Hepatocellular Carcinoma Persons having known allergy to saroglitazaar magnesium Persons having any other severe illness that may render the follow-up visits difficult Persons not giving written consent for the study

Design outcomes

Primary

Measure	Time frame
To see the improvement in liver steatosis and liver fibrosis in response to Saroglitazaar Magnesium 4mg or Dapagliglozin propendiol Monohydrate 10mgTimepoint: 6 months	—

Secondary

Measure	Time frame
To see the improvement in Liver Function TestTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDR DINESH KUMAR

HARSHA CLINIC AND DIABETES CENTRE

dineshharshaclinic@gmail.com7355389642

Outcome results

None listed

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