NCT07104786CompletedPhase 2
Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease
Effectiveness of Obeticholic Acid Versus Vitamin E in Patients of Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 29 Jul 2025
- Start date
- 24 Aug 2023
- Primary completion date
- 23 Nov 2023
- Lead sponsor
- King Edward Medical University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07104786
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From 24 Aug 2023 to the primary completion date, 23 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol
Other illness
- 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
- Patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension
Other
- Patients with significant alcohol intake (more than 20 g/day in women and \>30g/day in men)
- Pregnant and lactating females
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Edward Medical University, Mayo Hospital, Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.