Ulcerative ColitisPhase 2NCT05058417
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
A Phase 2 study testing Empagliflozin 10 MG in people with Ulcerative Colitis, run by Sadat City University at 1 site in Egypt.
Trial summary
This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 31 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- Adults (males and/or females) with age range from 18 to 65 years old.
- Patients on treatment with 5-aminosalisylic acid (5-ASA)
Who cannot join
- Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- Treatment with systemic or rectal steroids.
- Treatment with immunosuppressants.
- Previously failed treatment with a sulphasalazine.
- Known hypersensitivity to any of study drugs.
- Hepatic and renal dysfunction.
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- Pregnancy and lactation.
- History of colorectal carcinoma.
- History of complete or partial colectomy.
- Patients with diabetes mellitus
- Patients with history of lactic acidosis
- Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
- Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.
- Conditions
- Ulcerative Colitis
- Being tested
- Empagliflozin 10 MG, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
PlaceboDrug
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin group | Experimental | participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | participants will receive placebo for 8 consecutive weeks in addition to the standard therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of colonic (NF)-κB proteins
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Institutional and funding constrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058417
- Sponsor's protocol ID
- G12/2021
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05058417
- Acronym / sponsor ID
- G12/2021
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional and funding constrains
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Sep 2021 (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.
This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin group | Experimental | Drug: Empagliflozin 10 MGparticipants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy |
| Placebo | Placebo comparator | Drug: Placeboparticipants will receive placebo for 8 consecutive weeks in addition to the standard therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- Adults (males and/or females) with age range from 18 to 65 years old.
- Patients on treatment with 5-aminosalisylic acid (5-ASA)
Key exclusion criteria (13 listed)
- Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- Treatment with systemic or rectal steroids.
- Treatment with immunosuppressants.
- Previously failed treatment with a sulphasalazine.
- Known hypersensitivity to any of study drugs.
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 |
|---|---|---|
| Empagliflozin 10 MGparticipants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy | Drug | Empagliflozin group |
| Placeboparticipants will receive placebo for 8 consecutive weeks in addition to the standard therapy | Drug | Placebo |
Primary outcome
Expression of colonic (NF)-κB proteins
Time frame: 8 weeks
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes
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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 Empagliflozin 10 MG in people with Ulcerative Colitis, run by Sadat City 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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 14 Jul 2025. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Expression of colonic (NF)-κB proteins (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.