Not recruiting

Study on the Effects of Semaglutide on Insulin Resistance and Lipid Metabolism in Women with Obesity and Non-Alcoholic Fatty Liver Disease

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 weight loss on two health conditions: obesity and non-alcoholic fatty liver disease (NAFLD). The treatment being tested is a medication called Wegovy, which contains the active substance semaglutide. This medication is administered as a solution for injection using a pre-filled pen. The purpose of the study is to explore how significant weight loss affects the body's handling of certain fats and sugars, particularly in women who have both obesity and NAFLD.

Participants in the study will receive the treatment and be monitored over a period of time to observe changes in their health. The study will look at how the body processes very low-density lipoproteins (VLDL) and triglycerides, which are types of fats in the blood, before, during, and after weight loss. Researchers will also examine other health indicators, such as insulin resistance, which is how well the body uses insulin, and various markers of inflammation, which is the body's response to injury or infection.

The study will track changes in these health indicators over several months, comparing results from the beginning of the study to those after weight loss has stabilized. This will help researchers understand the relationship between weight loss and improvements in liver health and overall metabolism. The findings could provide valuable insights into managing obesity and NAFLD more effectively.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you meet the criteria such as having a body mass index (BMI) over 35 with certain health conditions or a BMI over 50.
You will undergo tests like MRS/MRI-PDFF to measure liver fat or a CAP test to assess liver steatosis.
Step 2
Treatment initiation
The treatment involves using a medication called Wegovy, which contains the active substance semaglutide. This is administered as a subcutaneous injection, meaning it is injected under the skin.
The dosage is 2.4 mg and it is provided in a pre-filled pen for ease of use. The frequency and duration of administration will be explained by the study team.
Step 3
Monitoring and follow-up
Throughout the study, regular monitoring will occur to track changes in weight, liver fat, and other health markers. This includes assessing very low-density lipoproteins and triglycerides (VLDL-TG) kinetics.
You will have scheduled visits to evaluate your progress and any changes in insulin resistance, circulating lipids, and other biochemical markers.
Step 4
Final assessment
After approximately 8 months, a final assessment will be conducted to evaluate the effects of the treatment. This includes measuring changes in VLDL-TG kinetics and liver fat content.
The study will also assess other health indicators such as inflammation markers and liver histology, if applicable.

Who can join the trial?

8 criteria

Must be a woman.
Must be 18 years or older.
Must have a Body Mass Index (BMI) over 35 with at least one of the following conditions:
- Osteoarthritis in the lower body joints, which means joint pain and stiffness.
- Documented sleep apnea, a condition where breathing stops and starts during sleep.
- Severe uncontrolled high blood pressure (hypertension).
- Must understand and speak Danish.
- Must have either:
  - An MRS/MRI-PDFF scan showing more than 5% fat in the liver.
  - A CAP (Controlled Attenuation Parameter) score greater than 280 dB/m, which is a measure of liver fat.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with both obesity and non-alcoholic fatty liver disease cannot participate.
Only women are eligible for this study, so men cannot participate.
Participants must be within a specific age range, so those outside this range cannot join.
Individuals who are considered part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Insulin is a hormone that helps control blood sugar levels in the body. In this trial, it is used to understand how weight loss affects the body's ability to manage sugar and fat, especially in people with obesity and fatty liver disease. Insulin helps the body use sugar from carbohydrates in the food you eat for energy or to store glucose for future use. It also helps keep your blood sugar level from getting too high or too low.

Semaglutide

What is already known about the treatment

Weight Loss Medication – This medication is administered orally and is currently being studied for its effects on obesity and non-alcoholic fatty liver disease. It is in the research phase, with ongoing clinical trials exploring its impact on insulin resistance and lipid metabolism. The main therapeutic use is to aid in significant weight loss, which may improve liver health and reduce fat accumulation. At the molecular level, it works by altering the body's metabolism of fats and sugars, potentially improving how the body processes these substances. It is classified as an anti-obesity agent.

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 calorie intake and energy expenditure, leading to weight gain. Over time, this excess weight can affect various bodily systems, including the cardiovascular and metabolic systems. As obesity progresses, it can lead to increased fat storage in tissues and organs, contributing to further health complications. The condition is often associated with other metabolic disorders, such as insulin resistance. Obesity can also impact physical mobility and overall quality of life.
Non-alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver Disease (NAFLD) is a condition where excess fat builds up in the liver in individuals who consume little to no alcohol. It typically begins with simple steatosis, where fat accumulates in liver cells without causing significant damage. As the disease progresses, it can lead to inflammation and liver cell injury, a condition known as non-alcoholic steatohepatitis (NASH). Over time, persistent inflammation may result in fibrosis, where scar tissue forms in the liver. If fibrosis continues to develop, it can lead to cirrhosis, a severe form of liver damage. NAFLD is often associated with metabolic conditions such as obesity and insulin resistance.