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

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-504988-16-00
• Lead Sponsor: Institut Klinicke A Experimentalni Mediciny

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified