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Completed NCT07701005

Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity

Conditions: Steatosis of Liver, Metabolic Liver Injury, Obesity, Overweight, Insulin Resistance

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 154
Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital

Location: Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital Istanbul

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 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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07701005). StuddyBuddy aggregates publicly available trial information.