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Completed

NCT Number: NCT05768334

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

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hepatology and Tropical Medicine Research Institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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).
  • 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.

Treatment and study plan

Lubiprostone 24Mcg Oral twice daily

Drug

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.

Primary outcomes

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

    Time frame: 48 weeks

    change in fat quantification

Secondary outcomes

  1. FibroScan with CAP (Controlled Attenuation Parameter)

    Time frame: 48 weeks

    change in fat quantification

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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