Who is sponsoring NCT05573204?

NCT05573204 is sponsored by Tanta University.

What drugs are being tested in NCT05573204?

Interventions in NCT05573204: Obeticholic Acid Oral Tablet, Vit E.

What condition does NCT05573204 study?

NCT05573204 studies Non-alcoholic Steatohepatitis.

Is NCT05573204 still recruiting?

NCT05573204 is currently active, enrolled. Last updated 10 January 2025.

Last reviewed 2025-01-10 · How we verify

NCT05573204

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

Active, enrolled Phase 2 Last updated 10 January 2025

What this trial tests

Phase 2 trial testing Obeticholic Acid Oral Tablet in Non-alcoholic Steatohepatitis in 59 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2021

Primary endpoint
25 October 2026

30 December 2026

Quick facts

Lead sponsor	Tanta University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	1 September 2021
Primary completion	25 October 2026
Estimated completion	30 December 2026
Sites	1 location across Egypt

Drugs / interventions tested

Obeticholic Acid Oral Tablet — full drug profile →
Vit E — full drug profile →

Conditions studied

Non-alcoholic Steatohepatitis — all drugs for Non-alcoholic Steatohepatitis →

Sponsor

Tanta University

Who can join

Adults 18 to 70, any sex, with Non-alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims at evaluating and comparing the protective outcomes of using Obeticholic acid versus Vitamin E in NASH patients without cirrhosis. The intervention is 6-months duration and the study will assess the efficacy of either drug as fibrosis improvement (≥ 1 stage) with no worsening of NASH or NASH resolution with no worsening of fibrosis with the study considered successful if either 1ry end point is met. . Also, assessment of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance and liver fibrosis will be done.

Publications & conference data

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

Understanding NAFLD: From Case Identification to Interventions, Outcomes, and Future Perspectives.
Clayton-Chubb D, Kemp W, Majeed A, Lubel JS, et al · · 2023 · cited 26× · PMID 36771394 · DOI 10.3390/nu15030687
MetALD: Does it require a different therapeutic option?
Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
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
Pharmaceutical Strategies to Improve Druggability of Potential Drug Candidates in Nonalcoholic Fatty Liver Disease Therapy.
Amatya R, Lee D, Min KA, Shin MC. · · 2023 · cited 9× · PMID 37514148 · DOI 10.3390/pharmaceutics15071963

Verify or expand the search:

Other recruiting trials for Non-alcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05945537 — A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH · Phase 1 · recruiting
NCT05462353 — Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH · Phase 2 · active not recruiting
NCT04822181 — Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) · Phase 3 · active not recruiting
NCT04666402 — Integrated Diagnostics for Early Diagnosis of Liver Disease · recruiting
NCT03535142 — Prognostic Significance of Fatty Liver Disease in Bariatric Patients · NA · recruiting

Other Tanta University trials

Trials by the same sponsor.

NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05573204 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tanta University
Last refreshed: 10 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05573204.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing