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NCT05561062
Atorvastatin in Patients With Ulcerative Colitis
Phase 2 trial testing Atorvastatin 80mg in Inflammatory Bowel Diseases in 50 participants. Completed in 1 November 2024.
1 November 2024
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 December 2022 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Atorvastatin 80mg — full drug profile →
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Tanta University
Who can join
Adults 18 to 75, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mitochondrial function and gastrointestinal diseases.
Haque PS, Kapur N, Barrett TA, Theiss AL. · · 2024 · cited 51× · PMID 38740978 · DOI 10.1038/s41575-024-00931-2 -
Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.
Khan S, Huda B, Bhurka F, Patnaik R, et al · · 2025 · cited 7× · PMID 40943351 · DOI 10.3390/ijms26178429 -
Effect of a high dose atorvastatin as adjuvant therapy to mesalamine in attenuating inflammation and symptoms in patients with ulcerative colitis: a randomized controlled pilot study.
Alarfaj SJ, El-Haggar SM, Hegazy SK, Maher MM, et al · · 2024 · cited 6× · PMID 39911672 · DOI 10.3389/fmed.2024.1490178 -
Repurposing Atorvastatin, HMGCO-A Reductase Inhibitor, in Patients with Ulcerative Colitis: A Randomized Controlled Study.
AlRasheed HA, El-Haggar SM, Hegazy SK, Maher MM, et al · · 2025 · cited 5× · PMID 40364108 · DOI 10.3390/jcm14093077 -
Lipid metabolism in homeostasis and disease.
Li Z, Deng W, Yang L, Tang C, et al · · 2026 · cited 2× · PMID 41692800 · DOI 10.1038/s41392-025-02357-x
Verify or expand the search:
- PubMed search for NCT05561062
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05912686 — High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients · Phase 4 · not yet recruiting
- NCT05792540 — Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Dis · Phase 2 · completed
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
- NCT07520747 — A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea · recruiting
- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT07033208 — Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance · NA · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · 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
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05561062 (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: 11 August 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/NCT05561062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing