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Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

NCT05011305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2025-10-24

No results posted yet for this study

Summary

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Conditions

Interventions

DRUG

Saroglitazar Magnesium 2 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

DRUG

Saroglitazar Magnesium 4 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

DRUG

Placebo

Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven V. Parmar, MD, FCP · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2025-09-12
Completion
2025-09-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Puerto Rico
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011305 on ClinicalTrials.gov