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Study on the Effects of Semaglutide on Liver Fat in Obese Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called semaglutide on people with obesity. The study aims to see how semaglutide affects the amount of fat in the liver and how the liver responds to a high-fat meal. Semaglutide is given as a solution for injection under the skin.

The purpose of the study is to determine if taking semaglutide for 16 weeks can positively change the liver's fat content and its reaction to consuming a high-fat meal. Participants will receive semaglutide injections and will be monitored over a period of 16 weeks. During this time, the study will measure changes in liver fat using a technique called magnetic resonance spectroscopy (MRS), which is a type of imaging test. The study will also look at changes in body weight, waist size, and other factors related to body fat and metabolism.

Throughout the study, participants will have their liver fat content measured before and after consuming a high-fat meal to see how it changes. Other health indicators, such as insulin resistance and levels of certain substances in the body that affect metabolism, will also be assessed. The study is expected to continue until the end of 2029.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes measuring body mass index (BMI), which should be 30 kg/m² or higher, and waist circumference, which should be 102 cm or more.

    A magnetic resonance spectroscopy (MRS) is performed to evaluate hepatic fat content. The hepatic fat content must be greater than 5.5% to proceed.

  2. Step 2

    Medication administration

    The medication used in this trial is semaglutide, administered through a subcutaneous injection. This means the medication is injected under the skin.

    The treatment with semaglutide lasts for 16 weeks. The specific dosage and frequency of administration will be provided by the study team.

  3. Step 3

    Regular monitoring

    Throughout the 16-week period, regular monitoring is conducted to assess the effects of the treatment. This includes measuring hepatic fat content and hepatic fat volume using MRS after 14 and 16 weeks.

    Additional assessments include measuring body weight, waist circumference, and body composition using specialized equipment.

  4. Step 4

    High-fat load test

    A high-fat load test is conducted to evaluate the acute response of hepatic fat content. This involves consuming a high-fat meal containing 150 g of fat.

    The hepatic fat content is measured before and 6 hours after the high-fat load to determine changes.

  5. Step 5

    Additional assessments

    Additional assessments include evaluating insulin resistance and changes in metabolic factors such as adipokines (e.g., adiponectin, leptin).

    These assessments are conducted after 14 and 16 weeks of treatment to understand the effects of semaglutide on liver fat and overall metabolism.

Who can join the trial?

5 criteria

  • Must be male.
  • Age between 18 and 70 years.
  • Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
  • Waist circumference of 102 cm or more. This is a measurement around the waist.
  • Hepatic fat content greater than 5.5% as evaluated by MRS during screening. Hepatic fat content refers to the amount of fat in the liver, and MRS is a type of scan used to measure it.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to help reduce liver fat in people who are obese and have a condition called MASLD, which affects the liver. The trial aims to see if taking semaglutide for 16 weeks can lower the amount of fat in the liver and improve how the liver responds to eating a high-fat meal. Semaglutide works by mimicking a hormone in the body that helps control blood sugar levels and appetite, which can lead to weight loss and potentially reduce liver fat. This study is exploring whether these effects can benefit liver health in the participants.

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied for its effects on liver fat in people with obesity, particularly in those with metabolic-associated steatotic liver disease (MASLD). The main therapeutic use of semaglutide is to help manage obesity by reducing body weight. At the molecular level, semaglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and food intake. It belongs to a class of drugs known as GLP-1 receptor agonists, which are used to improve blood sugar control and support weight loss.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between energy intake and energy expenditure, leading to an increase in body weight. Over time, this excess fat can accumulate in various parts of the body, including subcutaneous and visceral areas. As obesity progresses, it can lead to changes in body composition, such as increased waist circumference and body mass index (BMI). The condition is often associated with metabolic changes, including insulin resistance and alterations in the levels of hormones like adiponectin and leptin. Obesity can also affect liver function, contributing to increased hepatic fat content and volume.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504988-16-00Protocol codeIKEM-ISS-02Estimated enrolment16 patientsSponsorInstitut Klinicke A Experimentalni Mediciny

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