NCT04193982

An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Status unknown Phase 3 Last updated 26 January 2021

What this trial tests

Phase 3 trial testing Saroglitazar in NAFLD in 250 participants. Status unknown.

Timeline

31 January 2021

Primary endpoint
30 September 2021

31 October 2021

Quick facts

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	250
Start date	31 January 2021
Primary completion	30 September 2021
Estimated completion	31 October 2021
Sites	1 location across India

Drugs / interventions tested

• Saroglitazar (SAROGLITAZAR) — full drug profile →
• Vitamin E (VITAMIN E) — full drug profile →
• Combination drug
• Lifestyle Changes

Conditions studied

• NAFLD — all drugs for NAFLD →

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 60, any sex, with NAFLD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.

Publications & conference data

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

1. Targeting fibrosis, mechanisms and cilinical trials.
   Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
2. Metabolic liver disease in diabetes - From mechanisms to clinical trials.
   Dewidar B, Kahl S, Pafili K, Roden M. · · 2020 · cited 96× · PMID 32569680 · DOI 10.1016/j.metabol.2020.154299
3. Peroxisome Proliferator-Activated Receptors and Their Novel Ligands as Candidates for the Treatment of Non-Alcoholic Fatty Liver Disease.
   Fougerat A, Montagner A, Loiseau N, Guillou H, et al · · 2020 · cited 95× · PMID 32650421 · DOI 10.3390/cells9071638
4. The Role of the Gut-Liver Axis in Metabolic Dysfunction-Associated Fatty Liver Disease.
   Martín-Mateos R, Albillos A. · · 2021 · cited 88× · PMID 33936094 · DOI 10.3389/fimmu.2021.660179
5. Transcriptional Regulation of Metabolic Pathways via Lipid-Sensing Nuclear Receptors PPARs, FXR, and LXR in NASH.
   Cariello M, Piccinin E, Moschetta A. · · 2021 · cited 71× · PMID 33545430 · DOI 10.1016/j.jcmgh.2021.01.012
6. 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
7. 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
8. Updates on novel pharmacotherapeutics for the treatment of nonalcoholic steatohepatitis.
   Yang YY, Xie L, Zhang NP, Zhou D, et al · · 2022 · cited 42× · PMID 35190696 · DOI 10.1038/s41401-022-00860-3