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Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity (GLP-NIT)

13 juli 2026 bijgewerkt door: Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

154

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
      • Istanbul, Turkije (Türkiye)
        • Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: Semaglutide
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.
Andere namen:
  • Ozempic; Wegovy
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.
Geneesmiddel: Tirzepatide
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.
Andere namen:
  • Mounjaro; Zepbound

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Fibrosis-4 Index (FIB-4)
Tijdsspanne: 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.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in AST-to-Platelet Ratio Index (APRI)
Tijdsspanne: 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.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Hepatic Steatosis Index (HSI)
Tijdsspanne: 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.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Triglyceride-Glucose (TyG) Index
Tijdsspanne: 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.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Liver Enzymes
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
AST, ALT, and GGT levels (U/L).
Baseline and follow-up (median 23.7 weeks)
Change in Lipid Profile
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
Total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)
Baseline and follow-up (median 23.7 weeks)
Change in Fasting Plasma Glucose
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
Fasting plasma glucose (mg/dL)
Baseline and follow-up (median 23.7 weeks)
Change in Body Weight
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
Body weight (kilograms).
Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
HbA1c (percentage of total hemoglobin, %).
Baseline and follow-up (median 23.7 weeks)
Change in Body Mass Index (BMI)
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
BMI (kg/m^2), calculated from body weight and height.
Baseline and follow-up (median 23.7 weeks)
Change in Waist-to-Height Ratio
Tijdsspanne: Baseline and follow-up (median 23.7 weeks)
Waist-to-height ratio (unitless ratio: waist circumference [cm] / height [cm]).
Baseline and follow-up (median 23.7 weeks)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Onderzoekers

  • Hoofdonderzoeker: Ozgur Bahadir, MD, Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
  • Studie directeur: Ayse N Erbakan, MD,PhD, Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2024

Primaire voltooiing (Werkelijk)

30 maart 2026

Studie voltooiing (Werkelijk)

15 april 2026

Studieregistratiedata

Eerst ingediend

7 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

13 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GLP-NIT

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Data available from the corresponding author upon reasonable request

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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