NCT05768334

Brief 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 Medicine Research Institute (NHTMRI). Study design: Randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2020

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

Study Start

First participant enrolled

November 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

March 2, 2023

Last Update Submit

December 7, 2023

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).

    change in fat quantification

    48 weeks

Secondary Outcomes (1)

  • FibroScan with CAP (Controlled Attenuation Parameter)

    48 weeks

Study Arms (2)

lubiprostone

ACTIVE COMPARATOR

50 patients

Drug: Lubiprostone 24Mcg Oral twice daily

Control arm

PLACEBO COMPARATOR

50 patients

Drug: Lubiprostone 24Mcg Oral twice daily

Interventions

Lubiprostone 24Mcg Oral twice dailyDRUG

The 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.

Control armlubiprostone

Eligibility Criteria

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

You may qualify if:

  • \- 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).
  • \. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4\<14.6KPa). 7. Hepatic steatosis \> 5% with MRI-PDFF.

You may not qualify if:

  • \. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).
  • \. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).
  • \. 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).
  • \. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hepatology and Tropical Medicine Research Institute

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 39744921DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and chief of Endemic Medicine Department

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 14, 2023

Study Start

November 1, 2020

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

EG(1)