Non-alcoholic Fatty Liver DiseasePhase 4NCT05813249
Semaglutide in Nonalcoholic Fatty Liver Disease
A Phase 4 study testing Rybelsus Oral Product, Ozempic Injectable Product and Tocopherol and/or Actos in people with Non-alcoholic Fatty Liver Disease, run by Zagazig University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Rybelsus Oral Product, Ozempic Injectable Product and Tocopherol and/or Actos
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Rybelsus Oral Product, Ozempic Injectable Product, Tocopherol and/or Actos
- Keywords
- Semaglutide, Non-alcoholic Fatty Liver Disease, Obesity, Type 2 Diabetes Mellitus
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rybelsus Oral ProductDrug
Oral Semaglutide
Ozempic Injectable ProductDrug
Also called Wegovy
Subcutaneous Semaglutide
Tocopherol and/or ActosDrug
Vitamin E and/or Pioglitazone
| Study group | Role | What they receive |
|---|---|---|
| NAFLD1 | Active comparator | Hepatic steatosis Receives: Drug: Rybelsus Oral Product |
| NAFLD2 | Active comparator | Hepatic steatosis Receives: Drug: Ozempic Injectable Product |
| NAFLD3 | Active comparator | Hepatic steatosis Receives: Drug: Tocopherol and/or Actos |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAFLD regression
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)
Measured: 48 weeks
Secondary outcomes (1)
Fibrosis regression
improvement of liver stiffness evaluated by Fibroscan (kPa) and
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start15 Feb 2023
- Primary completion15 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayman Magd Eldin Mohammad Sadek, Zagazig University
- Investigators
- Ayman Sadek, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813249
- Sponsor's protocol ID
- ZU-IRB#10461/15-2-2023
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05813249
- Acronym / sponsor ID
- ZU-IRB#10461/15-2-2023
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Semaglutide, Non-alcoholic Fatty Liver Disease, Obesity, Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAFLD1 | Active comparator | Drug: Rybelsus Oral ProductHepatic steatosis |
| NAFLD2 | Active comparator | Drug: Ozempic Injectable ProductHepatic steatosis |
| NAFLD3 | Active comparator | Drug: Tocopherol and/or ActosHepatic steatosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- Type 1 diabetes mellitus.
- DM, which is treated with insulin glargine.
- Alcohol consumption.
- Patients had bariatric surgery.
- Hepatitis C virus, hepatitis B virus, HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rybelsus Oral ProductOral Semaglutide | Drug | NAFLD1 |
| Ozempic Injectable ProductAlso: WegovySubcutaneous Semaglutide | Drug | NAFLD2 |
| Tocopherol and/or ActosVitamin E and/or Pioglitazone | Drug | NAFLD3 |
Primary outcome
NAFLD regression
Time frame: 48 weeks
improvement of severity of hepatic steatosis evaluated by CAP (dB/m)
1 secondary outcome
Fibrosis regression
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Sadek, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rybelsus Oral Product, Ozempic Injectable Product and Tocopherol and/or Actos in people with Non-alcoholic Fatty Liver Disease, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAFLD regression (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.