This clinical trial is focused on studying the effects of a medication called semaglutide in people with a liver condition known as non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, leading to inflammation and damage. The study aims to see if semaglutide can improve liver health in people with NASH who have a certain level of liver scarring, known as fibrosis stage 2 or 3.
Participants in the study will receive either semaglutide or a placebo, which is a substance with no active medication. The treatment is given as an injection under the skin using a pre-filled pen. The study is divided into two parts. In the first part, researchers will look at whether semaglutide can improve liver tissue health over a period of 72 weeks. In the second part, they will assess if semaglutide can reduce the risk of liver-related health issues over a longer period of 240 weeks.
The study will monitor various health indicators, including changes in liver tissue, body weight, and other health markers, to determine the effectiveness of semaglutide. Participants will be followed up regularly to track their progress and any changes in their condition. The goal is to gather information on whether semaglutide can be a beneficial treatment for people with NASH, potentially improving their liver health and reducing the risk of further liver damage.
1joining the study
Upon joining the study, participation begins with a baseline liver biopsy. This biopsy may be a recent one, taken within 180 days before the start of the study.
The biopsy is evaluated by a pathologist to confirm the presence of non-alcoholic steatohepatitis (NASH) and the stage of liver fibrosis.
2randomization and initial treatment
Participants are randomly assigned to receive either semaglutide or a placebo. Semaglutide is administered as a solution for injection.
The injection is given under the skin (subcutaneous) using a pre-filled pen or syringe.
3treatment phase part 1
The first part of the treatment phase lasts for 72 weeks. During this time, the effect of semaglutide on liver health is monitored.
The primary goal is to see if semaglutide can resolve steatohepatitis without worsening liver fibrosis.
4treatment phase part 2
The second part of the treatment phase extends to 240 weeks. The focus is on reducing the risk of liver-related health issues.
Participants continue to receive semaglutide or placebo injections throughout this period.
5monitoring and assessments
Regular assessments are conducted to monitor changes in liver health, body weight, and other health indicators.
These assessments include liver biopsies, blood tests, and other evaluations to track progress and any side effects.
6end of study
The study is expected to conclude in April 2029. At the end of the study, final assessments are conducted to evaluate the long-term effects of semaglutide.
The results will help determine the effectiveness of semaglutide in treating NASH and preventing liver-related complications.
Who Can Join the Study?
Must be 18 years or older at the time of agreeing to participate in the study.
Must have NASH (Non-alcoholic steatohepatitis) confirmed by a liver tissue sample. This sample can be from a test done up to 180 days before the first visit for the study.
Must have fibrosis stage 2 or 3. Fibrosis is a type of liver damage, and the stage indicates how severe it is.
Must have a NAS score of 4 or more. NAS stands for Nonalcoholic Fatty Liver Disease Activity Score, which measures liver health. The score should include at least 1 point each for fat in the liver, inflammation, and damaged liver cells.
Both men and women can participate.
Who Cannot Join the Study?
Patients who do not have Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition that involves inflammation and damage due to fat buildup in the liver.
Patients with liver fibrosis that is not at stage 2 or 3 are excluded. Fibrosis refers to the thickening and scarring of liver tissue.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
Patients who are considered part of a vulnerable population are not included in this study. A vulnerable population refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
Semaglutide is a medication being studied for its effects on liver health in people with a condition called non-cirrhotic non-alcoholic steatohepatitis (NASH). This condition involves liver inflammation and damage due to fat buildup in the liver, not related to alcohol use. The trial aims to see if semaglutide can improve liver tissue health and reduce the risk of liver-related health issues in patients with NASH and moderate to severe liver fibrosis.
Non-alcoholic steatohepatitis (NASH) – This is a liver disease characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH can progress to more severe liver conditions, such as fibrosis, where scar tissue forms in the liver. Over time, the fibrosis can worsen, leading to cirrhosis, which is a late stage of liver scarring. The disease often develops in individuals who are overweight or have diabetes, but it can also occur in those without these conditions. Symptoms may not be noticeable in the early stages, making it challenging to detect without medical testing.
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