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

13 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

154

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Médicament: 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.
Autres noms:
  • 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.
Médicament: 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.
Autres noms:
  • Mounjaro; Zepbound

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Fibrosis-4 Index (FIB-4)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Liver Enzymes
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and follow-up (median 23.7 weeks)
Body weight (kilograms).
Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
Délai: 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)
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Goztepe Prof Dr Suleyman Yalcın City Hospital

Les enquêteurs

  • Chercheur principal: Ozgur Bahadir, MD, Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
  • Directeur d'études: Ayse N Erbakan, MD,PhD, Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2024

Achèvement primaire (Réel)

30 mars 2026

Achèvement de l'étude (Réel)

15 avril 2026

Dates d'inscription aux études

Première soumission

7 juillet 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GLP-NIT

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Data available from the corresponding author upon reasonable request

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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