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Semaglutide in Nonalcoholic Fatty Liver Disease

NCT05813249 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Rybelsus Oral Product

Oral Semaglutide

DRUG

Ozempic Injectable Product

Subcutaneous Semaglutide

DRUG

Tocopherol and/or Actos

Vitamin E and/or Pioglitazone

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Ayman Sadek, MD · Zagazig University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-02-15
Completion
2024-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813249 on ClinicalTrials.gov