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

Sponsor
Goztepe Prof Dr Suleyman Yalcın City Hospital
Study ID
NCT07701005
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    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.
  • Tirzepatide — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Jan 1, 2024
Status verified
Jul 2026
Primary completion
Mar 30, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
154 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in Fibrosis-4 Index (FIB-4) [ Time Frame: Baseline and follow-up (median 23.7 weeks; minimum 12 weeks) ]

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