Who is sponsoring NCT06677788?

NCT06677788 is sponsored by Tanta University.

What drugs are being tested in NCT06677788?

Interventions in NCT06677788: Roflumilast 500 Mcg Oral Tablet, Vitamin E capsule.

What condition does NCT06677788 study?

NCT06677788 studies Non-Alcoholic Steatohepatitis (NASH).

Is NCT06677788 still recruiting?

NCT06677788 is currently completed. Last updated 7 November 2024.

Last reviewed 2024-11-07 · How we verify

NCT06677788

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

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

Completed Phase 2 Last updated 7 November 2024

What this trial tests

Phase 2 trial testing Roflumilast 500 Mcg Oral Tablet in Non-Alcoholic Steatohepatitis (NASH) in 55 participants. Completed in 15 October 2024.

Timeline

1 April 2022

Primary endpoint
20 September 2024

15 October 2024

Quick facts

Lead sponsor	Tanta University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	55
Start date	1 April 2022
Primary completion	20 September 2024
Estimated completion	15 October 2024
Sites	1 location across Egypt

Drugs / interventions tested

Roflumilast 500 Mcg Oral Tablet — full drug profile →
Vitamin E capsule — full drug profile →

Conditions studied

Non-Alcoholic Steatohepatitis (NASH) — all drugs for Non-Alcoholic Steatohepatitis (NASH) →

Sponsor

Tanta University

Who can join

19 and older, any sex, with Non-Alcoholic Steatohepatitis (NASH). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH. Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting Phosphodiesterase 4 in Gastrointestinal and Liver Diseases: From Isoform-Specific Mechanisms to Precision Therapeutics.
Chen C, Liu M, Tao X. · · 2025 · cited 1× · PMID 40564004 · DOI 10.3390/biomedicines13061285

Verify or expand the search:

Other trials of Roflumilast 500 Mcg Oral Tablet

Trials testing the same drug.

NCT05682859 — Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) · Phase 4 · unknown
NCT03532490 — Trial of Roflumilast in Asthma Management (TRIM) · Phase 2 · completed
NCT06643221 — Exercise as an Immune Adjuvant for Allogeneic Cell Therapies · EARLY_PHASE1 · recruiting

Other recruiting trials for Non-Alcoholic Steatohepatitis (NASH)

Currently open trials in the same condition.

NCT06724913 — Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice C · NA · active not recruiting
NCT03151473 — Longitudinal Observational Study Of Chinese With NAFLD/NASH · 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 NCT06677788 (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: 7 November 2024

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/NCT06677788.

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