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