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Semaglutide in Nonalcoholic Fatty Liver Disease

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Rybelsus Oral Product
Ozempic Injectable Product
Tocopherol and/or Actos
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Semaglutide, Non-alcoholic Fatty Liver Disease, Obesity, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

NAFLD1

NAFLD2

NAFLD3

Arm Description

Hepatic steatosis

Hepatic steatosis

Hepatic steatosis

Outcomes

Primary Outcome Measures

NAFLD regression
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)

Secondary Outcome Measures

Fibrosis regression
improvement of liver stiffness evaluated by Fibroscan (kPa) and

Full Information

First Posted
March 19, 2023
Last Updated
April 1, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05813249
Brief Title
Semaglutide in Nonalcoholic Fatty Liver Disease
Official Title
Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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: Site of study: This study will be conducted in Internal Medicine Department, at Zagazig University Hospitals. Type of study: This study is an open-label clinical trial. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Semaglutide, Non-alcoholic Fatty Liver Disease, Obesity, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAFLD1
Arm Type
Active Comparator
Arm Description
Hepatic steatosis
Arm Title
NAFLD2
Arm Type
Active Comparator
Arm Description
Hepatic steatosis
Arm Title
NAFLD3
Arm Type
Active Comparator
Arm Description
Hepatic steatosis
Intervention Type
Drug
Intervention Name(s)
Rybelsus Oral Product
Intervention Description
Oral Semaglutide
Intervention Type
Drug
Intervention Name(s)
Ozempic Injectable Product
Other Intervention Name(s)
Wegovy
Intervention Description
Subcutaneous Semaglutide
Intervention Type
Drug
Intervention Name(s)
Tocopherol and/or Actos
Intervention Description
Vitamin E and/or Pioglitazone
Primary Outcome Measure Information:
Title
NAFLD regression
Description
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Fibrosis regression
Description
improvement of liver stiffness evaluated by Fibroscan (kPa) and
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed I. Gad, MD
Phone
1148419115
Ext
+20
Email
ahmedgadmed@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nevin F. Ibrahim, MD
Phone
1555544259
Ext
+20
Email
nova.fayek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Sadek, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr T. EL Hawary, MD
Phone
1003087983
Ext
+20
Email
Dramrelhawary@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Semaglutide in Nonalcoholic Fatty Liver Disease

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