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NCT05561062

Atorvastatin in Patients With Ulcerative Colitis

Completed Phase 2 Last updated 11 August 2025
What this trial tests

Phase 2 trial testing Atorvastatin 80mg in Inflammatory Bowel Diseases in 50 participants. Completed in 1 November 2024.

Timeline
1 December 2022
Primary endpoint
1 November 2024
1 November 2024

Quick facts

Lead sponsorTanta University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment50
Start date1 December 2022
Primary completion1 November 2024
Estimated completion1 November 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

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):

  1. 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
  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
  3. 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
  4. 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
  5. 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:

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Data sources for this page

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