NCT05011305: NASH

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Completed Phase 2 Last updated 24 October 2025

What this trial tests

Phase 2 trial testing Saroglitazar Magnesium 2 mg in Nonalcoholic Steatohepatitis in 189 participants. Completed in 12 September 2025.

Timeline

18 August 2021

Primary endpoint
12 September 2025

12 September 2025

Quick facts

Lead sponsor	Zydus Therapeutics Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	189
Start date	18 August 2021
Primary completion	12 September 2025
Estimated completion	12 September 2025
Sites	129 locations across Argentina, Puerto Rico, United States, Turkey (Türkiye)

Drugs / interventions tested

• Saroglitazar Magnesium 2 mg — full drug profile →
• Saroglitazar Magnesium 4 mg — full drug profile →
• Placebo

Conditions studied

• Nonalcoholic Steatohepatitis — all drugs for Nonalcoholic Steatohepatitis →
• Fibrosis — all drugs for Fibrosis →

Sponsor

Zydus Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis or Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PPAR-Targeted Therapies in the Treatment of Non-Alcoholic Fatty Liver Disease in Diabetic Patients.
   Lange NF, Graf V, Caussy C, Dufour JF. · · 2022 · cited 52× · PMID 35457120 · DOI 10.3390/ijms23084305
2. Treatment of liver fibrosis: Past, current, and future.
   Zhang CY, Liu S, Yang M. · · 2023 · cited 49× · PMID 37397931 · DOI 10.4254/wjh.v15.i6.755
3. Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
   Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
4. Functional and Structural Insights into the Human PPARα/δ/γ Targeting Preferences of Anti-NASH Investigational Drugs, Lanifibranor, Seladelpar, and Elafibranor.
   Kamata S, Honda A, Ishikawa R, Akahane M, et al · · 2023 · cited 28× · PMID 37627519 · DOI 10.3390/antiox12081523
5. MetALD: Does it require a different therapeutic option?
   Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
6. Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
   Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
7. Pathophysiological Relationship between Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease: Novel Therapeutic Approaches.
   Ferdous SE, Ferrell JM. · · 2024 · cited 20× · PMID 39201418 · DOI 10.3390/ijms25168731
8. Lessons on Drug Development: A Literature Review of Challenges Faced in Nonalcoholic Fatty Liver Disease (NAFLD) Clinical Trials.
   Chen JYS, Chua D, Lim CO, Ho WX, et al · · 2022 · cited 20× · PMID 36613602 · DOI 10.3390/ijms24010158