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The effect of semaglutide therapy on hepatic fat content and on the acute response of liver fat to high-fat load

Key facts

Where
Prague 4, CsehországSee the site
Phase
3. fázis

Where in Csehország

  • Institut Klinicke A Experimentalni MedicinyPrague 4, CsehországToborzás még nem indult

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Trial details

Who runs it
Institut Klinicke A Experimentalni Mediciny
Trial code
EU 2023-504988-16-00
Record updated
2025. május 28.
Original description
- to determine whether the treatment with semaglutide for 16 weeks favorably affects hepatic fat volume - to determine whether the treatment with semaglutide for 16 weeks favorably affects the acute response of hepatic fat content to a high-fat loadRead full original descriptionShow less

The effect of semaglutide therapy on hepatic fat content and on the acute reponse of liver fat to high-fat load in obese MASLD patients

- to determine whether the treatment with semaglutide for 16 weeks favorably affects hepatic fat volume - to determine whether the treatment with semaglutide for 16 weeks favorably affects the acute response of hepatic fat content to a high-fat load

Inclusion: sex: male; age 18 – 70 years; BMI ≥ 30 kg/m2; waist circumference ≥102 cm; hepatic fat content evaluated by MRS during screening > 5,5 %.

Exclusion: chronic treatment with corticosteroids or immunosuppressants; significant change in weight (> 5 %) in the 3 months before the entering study; acute myocardial infarction, unstable angina pectoris, stroke, pulmonary embolism during 3 months before the start of study; diabetes mellitus Type I and Type II; active malignancy; history of liver transplantation or transplantation of insulin-producing tissue; any other disease that, in the opinion of investigator, could endanger or disadvantage the patient if he were to participate in the clinical trial; lactose intolerance, cow milk protein allergy or other intolerancies; hypersensitivity to the active substance or to any auxiliary substance of investigational medicinal product; heart failure NYHA IV; active hepatitis, liver cirrhosis; HbA1c ≥ 48 mmol/mol or fasting glycemia ≥ 7 mmol/l during screening; triglyceride > 4 mmol/l during screening; chronic renal insufficiency IV-V (eGFR ≤ 0,5 ml/s), end-stage renal failure, hemodialysis or peritoneal dialysis; alcohol consumption > 40 g/day; use of weight loss dugs; lack of legal capacity; refusal to sign informed consent; untreated thyreopathy; acute or chronic pancreatitis.

EU CTIS 2023-504988-16-00