Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05813249 |
| Other study ID # |
ZU-IRB#10461/15-2-2023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2023 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Rationale:
NAFLD is one of the major causes of chronic liver disease worldwide with the highest
prevalence in Middle East countries. No pharmaceutical agent until now approved to treat
hepatic steatosis. There is a potential effect of glucagon-like peptide-1 agonists in the
treatment of steatosis and improving the resulting steatohepatitis and fibrosis in obesity
and/or type 2 diabetes mellitus.
Research question:
Is the use of Semaglutide (oral or SC form) effective in improving NAFLD and its sequelae in
obesity and/or type 2 diabetes mellitus?
Hypothesis:
The investigators hypothesize that Semaglutide (oral or SC form) has a role in NAFLD
associated with obesity and/or type 2 diabetes mellitus.
Aim of the study:
To determine the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity
and/or type 2 diabetes mellitus.
Objectives:
- Determine the therapeutic effect of oral and SC Semaglutide in NAFLD and its sequelae in
obesity and/or type 2 diabetes mellitus.
- Compare oral and SC forms of Semaglutide.
- Evaluate the impact of the medication on glycemic control and weight loss.
Material and methods:
1. Site of study:
This study will be conducted in Internal Medicine Department, at Zagazig University
Hospitals.
2. Type of study:
This study is an open-label clinical trial.
3. Subjects allocation:
- Group 1: patients receive oral Semaglutide for NAFLD complicating obesity and/or
type 2 diabetes.
- Group 2: patients receive SC Semaglutide for NAFLD complicating obesity and/or type
2 diabetes.
- Group 3: patients receive conventional drug therapy for NAFLD (vitamin E and/or
pioglitazone) complicating obesity and/or type 2 diabetes.
- The patients receive medication at their own expense from a private pharmacy.
4. Steps of performance and techniques:
- Full medical history taking.
- Complete physical examination for all patients, calculating body mass index.
- Local examination of the liver.
- Calculation of BMI and measurement of waist circumference.
- Liver function tests.
- Complete blood count.
- Kidney function tests.
- Lipid profiles include total cholesterol, triglyceride, LDL, and HDL.
- Glucose metabolisms include fasting plasma glucose and HbA1c.
- Abdominal ultrasound.
- Fibroscan with CAP to assess liver stiffness (kPa) and liver steatosis (dB/m).
- FIB4 requires values of age, ALT, AST, and platelet count.
- NFS requires values of age, BMI, platelet count, albumin, hyperglycemia, and
ALT/AST ratio.
- Group 1 will receive oral Semaglutide with starting dose of 3mg daily then
up-titration to 14 mg for 48 weeks. Group 2 will receive injectable Semaglutide
starting with 0.25mg SC weekly for 4 weeks and up-titration gradually to reach 2mg
SC weekly for 48 weeks. Group 3 will receive Pioglitazone and/or Vitamin E.
