Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

NCT07104786 | Completed Phase 2 DMC

• 1 other identifier: No.166/RC/KEMU Date 08/06/2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Obeticholic acid; Vitamin E; Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Change in grade of NAFLD on ultrasound

  Improvement/ reduction on ultrasonography of at least one grade of NAFLD from baseline

  6 months

• Reduction of ALT levels

  25% reduction of ALT levels from baseline

  6 months

Study Arms (2)

Obeticholic acid (OCA) 10mg, Group A

EXPERIMENTAL

45 patients received 10mg of Obeticholic acid daily for 6 months

Drug: Obeticholic Acid 10 MG

Vitamin E 400mg twice daily, Group B

ACTIVE COMPARATOR

45 patients received 400mg of Vitamin E twice daily for 6 months

Dietary Supplement: Vitamin E 400mg

Interventions

Obeticholic Acid 10 MG DRUG

10mg OCA was given once daily for 6 months

Also known as: OCA

Obeticholic acid (OCA) 10mg, Group A

Vitamin E 400mg DIETARY_SUPPLEMENT

Vitamin E 400mg was given twice daily for 6 months

Also known as: Evion

Vitamin E 400mg twice daily, Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults of either gender between 18-75 years of age
• Any grade of NAFLD on ultrasonography (Grade 1 to 3)
• Raised ALT \>1.5 times the upper normal limit. (Normal reference \<40 IU in males, \<32 IU females)

You may not qualify if:

• Patients with significant alcohol intake (more than 20 g/day in women and \>30g/day in men)
• History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills)
• Patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism
• Pregnant and lactating females
• Patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension
• Patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University, Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (25)

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  BACKGROUND

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

obeticholic acid; Vitamin E; Tocopherols

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tazeen Nazar, MBBS,FCPSMed

  King Edward Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized Controlled Trial. Patients were randomly divided into two groups. Group A received 10mg Obeticholic acid once daily, whereas Group B received 400mg Vitamin E twice daily. Both groups were treated for 6 months. Changes in grade of NAFLD on ultrasound and ALT levels were monitored.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 24, 2023
• Primary Completion: November 23, 2023
• Study Completion: May 23, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)