NAFLDPhase 3NCT05768334
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
A Phase 3 study testing Lubiprostone 24Mcg Oral twice daily in people with NAFLD, run by Helwan University at 1 site in Egypt.
Trial summary
Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD). This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Lubiprostone 24Mcg Oral twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Feb 2023
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen \&Hepatitis C virus Antibody).
- 4. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4<14.6KPa). 7. Hepatic steatosis > 5% with MRI-PDFF.
Who cannot join
- 1. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).
- 2. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).
- 3. Child-Pugh score > 7. 4. Cirrhotic patients diagnosed by fibroScan (F4>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).
- 8. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).
This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI).
Study design: Randomized controlled trial.
- Conditions
- NAFLD
- Being tested
- Lubiprostone 24Mcg Oral twice daily
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubiprostone 24Mcg Oral twice dailyDrug
The patients will be randomized (closed envelopes) into one of two groups:
- Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily.
- Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| lubiprostone | Active comparator | 50 patients Receives: Drug: Lubiprostone 24Mcg Oral twice daily |
| Control arm | Placebo comparator | 50 patients Receives: Drug: Lubiprostone 24Mcg Oral twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
change in fat quantification
Measured: 48 weeks
Secondary outcomes (1)
FibroScan with CAP (Controlled Attenuation Parameter)
change in fat quantification
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Nov 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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 NAFLDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Kassas, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768334
- Sponsor's protocol ID
- 11-2020
- Status last verified
- Dec 2023
- First submitted
- 2 Mar 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Kassas M, Mostafa H, Abdellatif W, Shoman S, Esmat G, Brahmania M, Liu H, Lee SS. Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial. Aliment Pharmacol Ther. 2025 Feb;61(4):628-635. doi: 10.1111/apt.18478. Epub 2025 Jan 2.
PubMed 39744921
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05768334
- Acronym / sponsor ID
- 11-2020
- Conditions
- NAFLD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 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.
Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).
This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI).
Study design: Randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lubiprostone | Active comparator | Drug: Lubiprostone 24Mcg Oral twice daily50 patients |
| Control arm | Placebo comparator | Drug: Lubiprostone 24Mcg Oral twice daily50 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen \&Hepatitis C virus Antibody).
- 4. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4<14.6KPa). 7. Hepatic steatosis > 5% with MRI-PDFF.
Key exclusion criteria (4 listed)
- 1. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).
- 2. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).
- 3. Child-Pugh score > 7. 4. Cirrhotic patients diagnosed by fibroScan (F4>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).
- 8. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.
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 |
|---|---|---|
| Lubiprostone 24Mcg Oral twice dailyThe patients will be randomized (closed envelopes) into one of two groups: 1. Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. 2. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks. | Drug | Control arm, lubiprostone |
Primary outcome
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
Time frame: 48 weeks
change in fat quantification
1 secondary outcome
FibroScan with CAP (Controlled Attenuation Parameter)
Time frame: 48 weeks
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 Dec 2023.
- Derived from this study: PubMed 39744921El-Kassas M, Mostafa H, Abdellatif W, Shoman S, Esmat G, Brahmania M, Liu H, Lee SS. Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial. Aliment Pharmacol Ther. 2025 Feb;61(4):628-635. doi: 10.1111/apt.18478. Epub 2025 Jan 2.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Lubiprostone 24Mcg Oral twice daily in people with NAFLD, run by Helwan 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 2 inclusion and 4 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 Dec 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction). (time frame: 48 weeks). 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 NCT05768334, 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 Dec 2023.