Steatosis of LiverGLP-NITNCT07701005
Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity
An observational study of Steatosis of Liver and Metabolic Liver Injury, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose [TyG] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Steatosis of Liver, Metabolic Liver Injury, Obesity
- What is being tested?
- Semaglutide and Tirzepatide
- Type of treatment
- Injection or infusion
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Apr 2026
- Phase
- Observational
- 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
Study population: Adults with overweight or obesity at increased metabolic risk for MASLD, treated with subcutaneous semaglutide or tirzepatide for at least 12 weeks at a single tertiary-care internal medicine clinic in Turkey; both medications were self-funded (out-of-pocket), as they are not covered by the national health insurance system.
Who may be able to join
- Adults aged 18 years or older
- Overweight (BMI 25.0-29.9 kg/m²) or obesity (BMI ≥30.0 kg/m²)
- Considered at increased metabolic risk for MASLD (overweight/obesity plus ≥1 additional cardiometabolic risk factor)
- Continuous treatment with subcutaneous semaglutide or tirzepatide for at least 12 weeks
Who cannot join
- Significant alcohol consumption (>30 g/day for men; >20 g/day for women)
- Chronic liver disease of other etiology (viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease)
- Prior bariatric surgery
- Initiation or dose modification of pioglitazone, SGLT-2 inhibitors, or high-dose vitamin E within 3 months before baseline
- Concurrent use of known hepatotoxic agents (e.g., amiodarone, methotrexate)
- Missing clinical, anthropometric, or laboratory data at baseline or follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul
About this study
Official title: Early Changes in Non-Invasive Hepatic and Metabolic Indices After Incretin-Based Therapy in Patients With Overweight or Obesity: Real-World Evidence From a Turkish Cohort
This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose [TyG] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk reduction related to metabolic dysfunction-associated steatotic liver disease (MASLD). Baseline and follow-up (minimum 12 weeks) clinical, anthropometric, and laboratory data from 154 patients treated at a single tertiary-care center in Turkey were analyzed. The study assessed whether short-term incretin-based therapy was associated with changes in fibrosis-related indices (FIB-4, APRI) versus steatosis- and insulin resistance-related indices (HSI, TyG), and identified independent predictors of these changes using multivariable linear regression.
Read the detailed description
Adults aged 18 years or older with overweight or obesity who were considered at increased metabolic risk for MASLD and who received continuous subcutaneous semaglutide or tirzepatide for at least 12 weeks were retrospectively identified at the internal medicine clinic of a tertiary-care state hospital in Istanbul, Turkey. Patients with significant alcohol consumption, other chronic liver disease etiologies, prior bariatric surgery, recent initiation/dose change of MASLD-relevant medications, concurrent hepatotoxic agent use, or missing baseline/follow-up data were excluded.
Baseline values were defined as the most recent measurements within 4 weeks before treatment initiation; follow-up values were the earliest measurements obtained after at least 12 continuous weeks of therapy. FIB-4, APRI, HSI, and TyG were calculated at both time points. Wilcoxon signed-rank tests compared baseline-to-follow-up changes. Kendall's tau assessed exploratory correlations among change scores; Spearman's rho assessed two prespecified correlations (percentage body-weight change vs. index changes; ΔHbA1c vs. index changes in the diabetic subgroup). Multivariable linear regression (enter method) identified independent predictors of ΔFIB-4, ΔAPRI, ΔHSI, and ΔTyG, adjusting for baseline index value, weight change, follow-up duration, baseline HbA1c, sex, and age.
Agent choice (semaglutide vs. tirzepatide) and dose titration were at the discretion of the treating physician; patients receiving either agent were analyzed together as a drug class, without dose-based stratification, since the study's aim was to characterize the class-level early index response rather than compare individual agents.
- Being tested
- Semaglutide, Tirzepatide
- Keywords
- MASLD, semaglutide, tirzepatide, FIB-4, Hepatic Steatosis Index, triglyceride-glucose index, incretin-based therapy, real-world evidence
- Medical subject headings
- Fatty Liver, Obesity, Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic; Wegovy
Once-weekly subcutaneous GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
TirzepatideDrug
Also called Mounjaro; Zepbound
Once-weekly subcutaneous dual GIP/GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous semaglutide for at least 12 weeks (n=81). Dose titration was at the treating physician's discretion. Receives: Drug: Semaglutide | |
| Tirzepatide | Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous tirzepatide for at least 12 weeks (n=73). Dose titration was at the treating physician's discretion. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibrosis-4 Index (FIB-4)
FIB-4 = (Age × AST) / (Platelet count × √ALT), calculated at baseline and after ≥12 weeks of therapy.
Measured: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in AST-to-Platelet Ratio Index (APRI)
APRI = (AST / 40 U/L ULN) / Platelet count × 100, calculated at baseline and after ≥12 weeks of therapy.
Measured: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Hepatic Steatosis Index (HSI)
HSI = 8 × (ALT/AST) + BMI + 2 (if type 2 diabetes) + 2 (if female), calculated at baseline and after ≥12 weeks of therapy.
Measured: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Triglyceride-Glucose (TyG) Index
yG = ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) / 2], calculated at baseline and after ≥12 weeks of therapy.
Measured: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Secondary outcomes (7)
Change in Liver Enzymes
AST, ALT, and GGT levels (U/L).
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Fasting Plasma Glucose
Fasting plasma glucose (mg/dL)
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Lipid Profile
Total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Body Weight
Body weight (kilograms).
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
HbA1c (percentage of total hemoglobin, %).
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Body Mass Index (BMI)
BMI (kg/m^2), calculated from body weight and height.
Measured: Baseline and follow-up (median 23.7 weeks)
Change in Waist-to-Height Ratio
Waist-to-height ratio (unitless ratio: waist circumference [cm] / height [cm]).
Measured: Baseline and follow-up (median 23.7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jan 2024
- Primary completion30 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatosis of LiverStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Ozgur Bahadir, MD, Principal investigator, Istanbul Medeniyet University, Faculty of Medicine, Department of GastroenterologyAyse N Erbakan, MD,PhD, Study director, Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701005
- Sponsor's protocol ID
- GLP-NIT
- Acronym
- GLP-NIT
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Changes in Non-Invasive Hepatic and Metabolic Indices After Incretin-Based Therapy in Patients With Overweight or Obesity: Real-World Evidence From a Turkish Cohort
- ClinicalTrials.gov ID
- NCT07701005
- Acronym / sponsor ID
- GLP-NIT / GLP-NIT
- Keywords
- MASLD, semaglutide, tirzepatide, FIB-4, Hepatic Steatosis Index, triglyceride-glucose index, incretin-based therapy, real-world evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 14 Jul 2026 (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.
This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose [TyG] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk reduction related to metabolic dysfunction-associated steatotic liver disease (MASLD). Baseline and follow-up (minimum 12 weeks) clinical, anthropometric, and laboratory data from 154 patients treated at a single tertiary-care center in Turkey were analyzed. The study assessed whether short-term incretin-based therapy was associated with changes in fibrosis-related indices (FIB-4, APRI) versus steatosis- and insulin resistance-related indices (HSI, TyG), and identified independent predictors of these changes using multivariable linear regression.
Detailed description
Adults aged 18 years or older with overweight or obesity who were considered at increased metabolic risk for MASLD and who received continuous subcutaneous semaglutide or tirzepatide for at least 12 weeks were retrospectively identified at the internal medicine clinic of a tertiary-care state hospital in Istanbul, Turkey. Patients with significant alcohol consumption, other chronic liver disease etiologies, prior bariatric surgery, recent initiation/dose change of MASLD-relevant medications, concurrent hepatotoxic agent use, or missing baseline/follow-up data were excluded.
Baseline values were defined as the most recent measurements within 4 weeks before treatment initiation; follow-up values were the earliest measurements obtained after at least 12 continuous weeks of therapy. FIB-4, APRI, HSI, and TyG were calculated at both time points. Wilcoxon signed-rank tests compared baseline-to-follow-up changes. Kendall's tau assessed exploratory correlations among change scores; Spearman's rho assessed two prespecified correlations (percentage body-weight change vs. index changes; ΔHbA1c vs. index changes in the diabetic subgroup). Multivariable linear regression (enter method) identified independent predictors of ΔFIB-4, ΔAPRI, ΔHSI, and ΔTyG, adjusting for baseline index value, weight change, follow-up duration, baseline HbA1c, sex, and age.
Agent choice (semaglutide vs. tirzepatide) and dose titration were at the discretion of the treating physician; patients receiving either agent were analyzed together as a drug class, without dose-based stratification, since the study's aim was to characterize the class-level early index response rather than compare individual agents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Drug: SemaglutideAdults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous semaglutide for at least 12 weeks (n=81). Dose titration was at the treating physician's discretion. |
| Tirzepatide | – | Drug: TirzepatideAdults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous tirzepatide for at least 12 weeks (n=73). Dose titration was at the treating physician's discretion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with overweight or obesity at increased metabolic risk for MASLD, treated with subcutaneous semaglutide or tirzepatide for at least 12 weeks at a single tertiary-care internal medicine clinic in Turkey; both medications were self-funded (out-of-pocket), as they are not covered by the national health insurance system.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Overweight (BMI 25.0-29.9 kg/m²) or obesity (BMI ≥30.0 kg/m²)
- Considered at increased metabolic risk for MASLD (overweight/obesity plus ≥1 additional cardiometabolic risk factor)
- Continuous treatment with subcutaneous semaglutide or tirzepatide for at least 12 weeks
Key exclusion criteria (6 listed)
- Significant alcohol consumption (>30 g/day for men; >20 g/day for women)
- Chronic liver disease of other etiology (viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease)
- Prior bariatric surgery
- Initiation or dose modification of pioglitazone, SGLT-2 inhibitors, or high-dose vitamin E within 3 months before baseline
- Concurrent use of known hepatotoxic agents (e.g., amiodarone, methotrexate)
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 |
|---|---|---|
| SemaglutideAlso: Ozempic; WegovyOnce-weekly subcutaneous GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability. | Drug | Semaglutide |
| TirzepatideAlso: Mounjaro; ZepboundOnce-weekly subcutaneous dual GIP/GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability. | Drug | Tirzepatide |
Primary outcome
Change in Fibrosis-4 Index (FIB-4)
Time frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
FIB-4 = (Age × AST) / (Platelet count × √ALT), calculated at baseline and after ≥12 weeks of therapy.
Change in AST-to-Platelet Ratio Index (APRI)
Time frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
APRI = (AST / 40 U/L ULN) / Platelet count × 100, calculated at baseline and after ≥12 weeks of therapy.
Change in Hepatic Steatosis Index (HSI)
Time frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
HSI = 8 × (ALT/AST) + BMI + 2 (if type 2 diabetes) + 2 (if female), calculated at baseline and after ≥12 weeks of therapy.
Change in Triglyceride-Glucose (TyG) Index
Time frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
yG = ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) / 2], calculated at baseline and after ≥12 weeks of therapy.
7 secondary outcomes
Change in Liver Enzymes
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Fasting Plasma Glucose
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Lipid Profile
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Body Weight
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Body Mass Index (BMI)
Time frame: Baseline and follow-up (median 23.7 weeks)
Change in Waist-to-Height Ratio
Time frame: Baseline and follow-up (median 23.7 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 15 Jul 2026.
- Individual participant dataSharing planned: No. Data available from the corresponding author upon reasonable request
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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.
Ozgur Bahadir, MD principal investigator
Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
Ayse N Erbakan, MD,PhD study director
Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatosis of Liver and Metabolic Liver Injury, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 15 Jul 2026. 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 Turkey (Türkiye). 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.
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?
Change in Fibrosis-4 Index (FIB-4) (time frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)). The study lists 4 primary outcomes in all. 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 15 Jul 2026.