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

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

154

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: 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.
Andre navne:
  • 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.
Medicin: 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.
Andre navne:
  • Mounjaro; Zepbound

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Fibrosis-4 Index (FIB-4)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Liver Enzymes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and follow-up (median 23.7 weeks)
Body weight (kilograms).
Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Efterforskere

  • Ledende efterforsker: Ozgur Bahadir, MD, Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
  • Studieleder: Ayse N Erbakan, MD,PhD, Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Faktiske)

30. marts 2026

Studieafslutning (Faktiske)

15. april 2026

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLP-NIT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data available from the corresponding author upon reasonable request

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