Semaglutide in Nonalcoholic Fatty Liver Disease

April 1, 2024 updated by: Ayman Magd Eldin Mohammad Sadek, Zagazig University

Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: NAFLD1
Hepatic steatosis
Drug: Rybelsus Oral Product
Oral Semaglutide
Active Comparator: NAFLD2
Hepatic steatosis
Drug: Ozempic Injectable Product
Subcutaneous Semaglutide
Other Names:
  • Wegovy
Active Comparator: NAFLD3
Hepatic steatosis
Drug: Tocopherol and/or Actos
Vitamin E and/or Pioglitazone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NAFLD regression
Time Frame: 48 weeks
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fibrosis regression
Time Frame: 48 weeks
improvement of liver stiffness evaluated by Fibroscan (kPa) and
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayman Sadek, MD, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZU-IRB#10461/15-2-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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