Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05768334

Enrollment

116

Registered

2023-03-14

Start date

2020-11-01

Completion date

2023-02-01

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD

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.

Interventions

DRUGLubiprostone 24Mcg Oral twice daily

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

\- 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).	48 weeks	change in fat quantification

Secondary

Measure	Time frame	Description
FibroScan with CAP (Controlled Attenuation Parameter)	48 weeks	change in fat quantification

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026