NCT05753267

Brief Summary

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of 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 Feb 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

February 22, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

February 22, 2023

Last Update Submit

May 1, 2026

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)

    HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms.

    6 months

Secondary Outcomes (1)

  • The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)

    6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Mesalamine group will receive 1 g mesalamine three times daily for 6 months

Drug: Mesalamine

Fenofibrate group

ACTIVE COMPARATOR

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

Drug: Fenofibrate 160mg

Interventions

MesalamineDRUG

Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC

Control Group
Fenofibrate 160mgDRUG

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of 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 males and females will be included
  • Negative pregnancy test and effective contraception.
  • Mild and moderate UC patients diagnosed and confirmed by an endoscope

You may not qualify if:

  • Breastfeeding
  • 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)

Tanta Unuversity

Tanta, 31527, Egypt

Location

Related Publications (1)

  • Aldossary KM, Abdallah MS, Kamal N, Bahgat MM, Alrubia S, Alsegiani AS, Bahaa MM, Hassan AS, El-Khateeb E. Therapeutic Modulation of IL-6/STAT-3 and Nitric Oxide by Fenofibrate in Patients With Ulcerative Colitis: A Randomized Controlled Pilot Study. Pharmacotherapy. 2025 Dec;45(12):840-851. doi: 10.1002/phar.70088. Epub 2025 Dec 2.

    PMID: 41330887DERIVED

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

February 22, 2023

First Posted

March 3, 2023

Study Start

February 28, 2023

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

May 4, 2026

Record last verified: 2026-05

Locations

EG(1)