NCT03836937: NAFLD

Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

Completed NA Last updated 17 May 2022

What this trial tests

NA trial testing Obeticholic acid in Non-Alcoholic Fatty Liver Disease in 70 participants. Completed in 31 December 2021.

Timeline

5 March 2019

Primary endpoint
30 November 2020

31 December 2021

Quick facts

Lead sponsor	Sir Salimullah Medical College Mitford Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	5 March 2019
Primary completion	30 November 2020
Estimated completion	31 December 2021
Sites	1 location across Bangladesh

Drugs / interventions tested

• Obeticholic acid (OBETICHOLIC ACID) — full drug profile →

Conditions studied

• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →

Sponsor

Sir Salimullah Medical College Mitford Hospital

Who can join

Adults 18 to 65, any sex, with Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be conducted upon the patients with fatty liver disease. Patients who will be diagnosed as a case of fatty liver disease by ultrasound with raised liver enzyme (ALT) will be primarily selected for the study. A total number of 70 patients will be randomly selected for the study that will also be divided into two groups for the study purpose. The patients will be informed about the details of the study. After getting the detail information those who will give informed written consent will be finally included in the study. One group of patients will be treated by both life style modification and Obeticholic acid. Another group of patients by only life style modification. After 3 months of treatment the two groups will be compared of improvement of fatty liver disease and liver enzyme by improvement of fibroscan with CAP value as well as improvement of ALT value.

Publications & conference data

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

1. Bile acid coordinates microbiota homeostasis and systemic immunometabolism in cardiometabolic diseases.
   Guan B, Tong J, Hao H, Yang Z, et al · · 2022 · cited 142× · PMID 35646540 · DOI 10.1016/j.apsb.2021.12.011
2. Why Bile Acids Are So Important in Non-Alcoholic Fatty Liver Disease (NAFLD) Progression.
   Gottlieb A, Canbay A. · · 2019 · cited 102× · PMID 31671697 · DOI 10.3390/cells8111358
3. 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
4. Bile Acid Receptors and the Gut-Liver Axis in Nonalcoholic Fatty Liver Disease.
   Xue R, Su L, Lai S, Wang Y, et al · · 2021 · cited 65× · PMID 34831031 · DOI 10.3390/cells10112806
5. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
   Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
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. Alcohol-Related Liver Disease: An Overview on Pathophysiology, Diagnosis and Therapeutic Perspectives.
   Ha Y, Jeong I, Kim TH. · · 2022 · cited 19× · PMID 36289791 · DOI 10.3390/biomedicines10102530
8. Linking Nonalcoholic Fatty Liver Disease and Brain Disease: Focusing on Bile Acid Signaling.
   Ren ZL, Li CX, Ma CY, Chen D, et al · · 2022 · cited 18× · PMID 36361829 · DOI 10.3390/ijms232113045