Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial.

Anudeep Katrevula; Rakesh Kalapala; Siddhant Agrawal; Nitin Jagtap; Pratik Chhabra; Anand V Kulkarni; Chandhana Merugu; Goutham Reddy Katukuri; Nageshwar Reddy Duvvur

doi:10.1007/s12664-025-01856-7

PubMed · 41066034

Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial.

Anudeep Katrevula·Rakesh Kalapala·Siddhant Agrawal·Nitin Jagtap·Pratik Chhabra·Anand V Kulkarni·Chandhana Merugu·Goutham Reddy Katukuri·Nageshwar Reddy Duvvur

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Abstract

BACKGROUND AND OBJECTIVES: Obesity is a leading risk factor for fatty liver disease and weight loss has been shown to improve liver parameters. This study evaluates the efficacy of oral semaglutide for weight loss in individuals with overweight or obesity, excluding those with diabetes mellitus. METHODS: A randomized, open-label, controlled trial was conducted at the Asian Institute of Gastroenterology, Hyderabad, from June 2022 to December 2023. Adults (≥ 18 years) with a body mass index (BMI) ≥ 30 or ≥ 27 with comorbidities (pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease) were randomized into two groups. Both groups received counselling on a reduced-calorie diet and increased physical activity. Group 1 also received oral semaglutide, starting at 3 mg/day and titrated to 14 mg/day over two to four weeks. The objectives were to assess the effects of semaglutide on weight loss, non-invasive markers of liver fibrosis and cardiometabolic parameters. (ClinicalTrials.gov ID: NCT05442450). RESULTS: Total 116 participants (58 per group) completed the study. At 28 weeks, the mean percentage weight reduction was -10.47% (SD 5.3) in the Semaglutide group vs. -2.4% (SD 4.5) in the control group (p < 0.001). Semaglutide treatment significantly improved alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) levels, along with reductions in the aspartate aminotransferase to platelet ratio index (APRI) score, liver fat content and liver stiffness. However, NFS (NAFLD fibrosis score) and FIB-4 (fibrosis-4 index) did not show significant reductions. Improvements in BMI, waist circumference, HbA1c, fasting insulin and C-reactive protein (CRP) were significantly greater with semaglutide (p < 0.001). Total fat mass decreased by 7.3 kg vs. 1.74 kg (p < 0.0001) in controls, while visceral fat ratings dropped by 3.67 vs. 0.6 (p < 0.0001). CONCLUSIONS: In adults with overweight or obesity without diabetes, oral semaglutide, combined with dietary and lifestyle modifications, led to significant and clinically meaningful weight loss and metabolic improvements compared to lifestyle modifications alone.

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Adult Female Humans Male Middle Aged Administration, Oral Diet, Reducing Glucagon-Like Peptides Liver Cirrhosis Obesity Overweight Semaglutide Treatment Outcome Weight Loss Fatty liver Clinical Trial, Phase IV Journal Article Randomized Controlled Trial

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Anudeep Katrevula, Rakesh Kalapala, Siddhant Agrawal, Nitin Jagtap, Pratik Chhabra, Anand V Kulkarni, Chandhana Merugu, Goutham Reddy Katukuri, Nageshwar Reddy Duvvur. 2025-10-09. Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial.. https://doi.org/10.1007/s12664-025-01856-7

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Administration, Oral subject Adult subject Fatty Liver subject Female subject Humans subject Journal Article subject Male subject Middle Aged subject Obesity subject Overweight subject Randomized controlled trials study

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