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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
EU CTIS ID: 2023-504988-16-00
What this study is testing
- 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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- sex: male
- age 18 – 70 years
- BMI ≥ 30 kg/m2
- waist circumference ≥102 cm
- hepatic fat content evaluated by MRS during screening > 5,5 %
You likely can't join if
- 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
See the full eligibility 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 %
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.