NCT05781698

Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

Completed Phase 2 Last updated 6 April 2025

What this trial tests

Phase 2 trial testing Mesalamine in Inflammatory Bowel Diseases in 60 participants. Completed in 20 December 2024.

Timeline

20 March 2023

Primary endpoint
20 October 2024

20 December 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	60
Start date	20 March 2023
Primary completion	20 October 2024
Estimated completion	20 December 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Mesalamine — full drug profile →
• Fenofibrate (FENOFIBRATE) — 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

Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent

Publications & conference data

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

1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
   Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
2. 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
3. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
   Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
4. Fenofibrate as an Adjunct Therapy for Ulcerative Colitis: Targeting Inflammation via SIRT1, NLRP3, and AMPK Pathways: A Randomized Controlled Pilot Study.
   Alarfaj SJ, Bahaa MM, Elmasry TA, Elberri EI, et al · · 2024 · cited 11× · PMID 39575188 · DOI 10.2147/dddt.s490772
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
6. Nucleotide-binding domain, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome: From action mechanism to therapeutic target in clinical trials.
   Zhang CY, Liu S, Sui YX, Yang M. · · 2025 · cited 1× · PMID 39958558 · DOI 10.4251/wjgo.v17.i2.100094
7. The NLRP3 Inflammasome: Mechanisms of Activation, Regulation, and Therapeutic Opportunities.
   Zou C, Jiang S, Li H, Zhao K, et al · · 2026 · PMID 41799937 · DOI 10.1002/mco2.70660
8. Inflammasomes in lymphocytes as therapeutic targets.
   Albakova Z. · · 2025 · PMID 40054124 · DOI 10.1016/j.tranon.2025.102342