Semaglutide in Nonalcoholic Fatty Liver Disease

• Status: Recruiting
• Trial end date: 2024-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The main question it aims to answer is:

• Is the use of Semaglutide (oral or subcutaneous form) effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus?

Participants will undergo:

• Abdominal ultrasound.

• Fibroscan with controlled attenuation parameter to assess liver stiffness (kPa) and liver steatosis (dB/m).

• Fibrosis-4 score requires values of age, alanine aminotransferase, aspartate aminotransferase, and platelet count.

• NAFLD Fibrosis Score requires values of age, BMI, platelet count, albumin, hyperglycemia, and ALT/AST ratio.

Researchers will compare:

• Group 1 will receive oral Semaglutide for 48 weeks.

• Group 2 will receive injectable Semaglutide for 48 weeks.

• Group 3 will receive Pioglitazone and/or Vitamin E. to see if there is an improvement in liver stiffness and severity of hepatic steatosis after 48 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zagazig University
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

• Patients diagnosed with NAFLD by non-invasive methods in the form of abdominal US or MRI, confirmed by a Fibroscan scan with CAP to assess the quantity of hepatic steatosis and severity of fibrosis up to 21 weeks before the start of the study and after treatment.

• Primary obesity with body mass index (BMI) > 30.

• Type 2 diabetes mellitus.

Exclusion Criteria:

• Type 1 diabetes mellitus.

• DM, which is treated with insulin glargine.

• Alcohol consumption.

• Patients had bariatric surgery.

• Hepatitis C virus, hepatitis B virus, HIV.

• Patients with peptic ulcer disease.

• Secondary obesity originated from hypothalamic or endocrinal disorders.

• Other causes of CLD.

• Decompensated liver disease.

• History of pancreatitis (acute or chronic).

• Hepato-biliary disorders.

• ALT and AST values > 5 times of upper normal limits.

• Severe cardiac disease.

• Patients treated with GLP-1 agonist within 90 days before screening.

• Patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).