2023-504988-16-00Not yet recruitingPhase 3
The effect of semaglutide therapy on hepatic fat content and on the acute response of liver fat to high-fat load
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
- 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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 17 Apr 2023
- Start date
- 1 Jan 2026
- Lead sponsor
- Institut Klinicke A Experimentalni Mediciny
- Diseases
- Obesity
- EU CT number
- 2023-504988-16-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 16
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with obesity and fat in the liver. They would take semaglutide for 16 weeks.
- Age
- 18 to 70 years
- Sex
- Men only
- Disease stage
- BMI of 30 kg/m2 or more, waist circumference of 102 cm or more, and liver fat above 5,5 % on an MRS scan at screening
- Earlier treatment
- No weight loss drugs; no long-term corticosteroids or immunosuppressants; no weight change of more than 5 % in the 3 months before the trial
- Biomarker or test result
- Liver fat content above 5,5 % measured by MRS during screening
Main reasons for not taking part
- Type I or Type II diabetes
- Active cancer or a past liver transplant
- Alcohol use above 40 g/day
- Active hepatitis, liver cirrhosis, or pancreatitis
- Severe kidney failure or dialysis
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- sex: male
- age 18 – 70 years
- BMI ≥ 30 kg/m2
- waist circumference ≥102 cm
- hepatic fat content evaluated by MRS during screening > 5,5 %
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Klinicke A Experimentalni Mediciny | Prague 4 | Czechia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.