NCT05813249CompletedPhase 4
Semaglutide in Nonalcoholic Fatty Liver Disease
Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 2 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 19 Mar 2023
- Start date
- 15 Feb 2023
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- Zagazig University
- NCT number
- NCT05813249
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 180
- From 15 Feb 2023 to the primary completion date, 15 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- DM, which is treated with insulin glargine.
- Patients had bariatric surgery.
- Patients treated with GLP-1 agonist within 90 days before screening.
Other illness
- Type 1 diabetes mellitus.
- Hepatitis C virus, hepatitis B virus, HIV.
- Patients with peptic ulcer disease.
- Secondary obesity originated from hypothalamic or endocrinal disorders.
- Decompensated liver disease.
- History of pancreatitis (acute or chronic).
- Hepato-biliary disorders.
- Severe cardiac disease.
- Patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Lab values
- ALT and AST values \> 5 times of upper normal limits.
Other
- Alcohol consumption.
- Other causes of CLD.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zagazig University Coordinator of this site? Confirm its status | Zagazig | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.