NCT05813249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

March 19, 2023

Last Update Submit

April 1, 2024

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

SemaglutideNon-alcoholic Fatty Liver DiseaseObesityType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • NAFLD regression

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

    48 weeks

Secondary Outcomes (1)

  • Fibrosis regression

    48 weeks

Study Arms (3)

NAFLD1

ACTIVE COMPARATOR

Hepatic steatosis

Drug: Rybelsus Oral Product

NAFLD2

ACTIVE COMPARATOR

Hepatic steatosis

Drug: Ozempic Injectable Product

NAFLD3

ACTIVE COMPARATOR

Hepatic steatosis

Drug: Tocopherol and/or Actos

Interventions

Rybelsus Oral ProductDRUG

Oral Semaglutide

NAFLD1
Ozempic Injectable ProductDRUG

Subcutaneous Semaglutide

Also known as: Wegovy
NAFLD2
Tocopherol and/or ActosDRUG

Vitamin E and/or Pioglitazone

NAFLD3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Ayman Sadek, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 14, 2023

Study Start

February 15, 2023

Primary Completion

February 15, 2024

Study Completion

April 1, 2024

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)