NCT05781698

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

March 11, 2023

Last Update Submit

April 3, 2025

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).

    • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).

    6 months

Secondary Outcomes (1)

  • The secondary endpoint is estimated by changes in serum biomarkers.

    6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months

Drug: Mesalamine

Fenofibrate group

ACTIVE COMPARATOR

Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months

Drug: MesalamineDrug: Fenofibrate

Interventions

MesalamineDRUG

mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis

Control GroupFenofibrate group
FenofibrateDRUG

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia

Fenofibrate group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Mild and moderate UC patients diagnosed and confirmed by endoscope

You may not qualify if:

  • Breast feeding Significant liver and kidney function abnormalities Colorectal cancer patients Other inflammatory bowel diseases (CD). Patients with severe UC Patients taking rectal or systemic steroids Patients taking immunosuppressives or biological therapies Addiction to alcohol and/or drugs Known allergy to the Fenofibrate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Location

Related Publications (1)

  • Alarfaj SJ, Bahaa MM, Elmasry TA, Elberri EI, El-Khateeb E, Hamouda AO, Salahuddin MM, Kamal M, Gadallah AA, Eltantawy N, Yasser M, Negm WA, Hamouda MA, Alsegiani AS, Alrubia S, Eldesoqui M, Abdallah MS. Fenofibrate as an Adjunct Therapy for Ulcerative Colitis: Targeting Inflammation via SIRT1, NLRP3, and AMPK Pathways: A Randomized Controlled Pilot Study. Drug Des Devel Ther. 2024 Nov 16;18:5239-5253. doi: 10.2147/DDDT.S490772. eCollection 2024.

    PMID: 39575188DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

MesalamineFenofibrate

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsFibric AcidsIsobutyratesButyratesAcids, AcyclicPhenyl EthersEthersBenzophenonesKetones

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

March 20, 2023

Primary Completion

October 20, 2024

Study Completion

December 20, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

EG(1)