A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease

Phase 3

• Conditions: Fatty Liver
• Interventions: Drug: Pioglitazone; Drug: Saroglitazar

• Registration Number: NCT02265276
• Lead Sponsor: Command Hospital, India

Brief Summary

Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.

Detailed Description

The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-10
• Last Update Submitted: 2014-10-14
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-16
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal

Exclusion Criteria

• Use of any drugs other than lifestyle modification for NAFLD, HbA1c > 8% FBS>200, Bilirubin > 1.5 mg/dL
• Any illness likely to cause transaminitis and positive viral markers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone Group	Pioglitazone	Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
Saroglitazar Group	Saroglitazar	Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in the NAFLD fibrosis score	At baseline and the end of 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in body composition	At baseline and the end of 24 weeks
Change in insulin resistance	At baseline and the end of 24 weeks
Change in lipid profile	At baseline and the end of 24 weeks
Change in HbA1c	At baseline and the end of 24 weeks

Trial Locations

Locations (1)

Command Hospital; 🇮🇳 Panchkula, Haryana, India