Inflammatory Bowel DiseasesPhase 2NCT05781698
Repurposing Fenofibrate in Modulating AMPK/NLRP3 Inflammasome in Patients With Ulcerative Colitis
A Phase 2 study testing Mesalamine and Fenofibrate in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mesalamine and Fenofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Menoufia University
Tanta, Shebeen El-Kom, 32511
About this study
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
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mesalamine, Fenofibrate
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis
FenofibrateDrug
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months Receives: Drug: Mesalamine |
| Fenofibrate group | Active comparator | Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months Receives: Drug: Mesalamine; Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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).
Measured: 6 months
Secondary outcomes (1)
The secondary endpoint is estimated by changes in serum biomarkers.
The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Mar 2023
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781698
- Sponsor's protocol ID
- 1-2023
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39575188
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Fenofibrate in Modulating AMPK/NLRP3 Inflammasome in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05781698
- Acronym / sponsor ID
- 1-2023
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: MesalamineThe control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months |
| Fenofibrate group | Active comparator | Drug: Mesalamine, Drug: FenofibratePatients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesalaminemesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis | Drug | Control Group, Fenofibrate group |
| FenofibrateFibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia | Drug | Fenofibrate group |
Primary outcome
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).
Time frame: 6 months
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).
1 secondary outcome
The secondary endpoint is estimated by changes in serum biomarkers.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39575188Alarfaj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesalamine and Fenofibrate in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.