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Study on the Effectiveness of NNC0194-0499 and Semaglutide in Treating Non-Alcoholic Steatohepatitis (NASH) in Patients with Fibrosis Stages 2-4

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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 a liver condition called non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, causing inflammation and damage. The study is investigating the effects of two medications, NNC0194-0499 and Semaglutide, which are being tested to see if they can help improve liver health in people with NASH. The medications are given as injections under the skin, and the study will compare their effects to a placebo.

The purpose of the study is to determine if the combination of NNC0194-0499 and Semaglutide can improve liver fibrosis, which is the scarring of liver tissue, in people with NASH. Participants in the study will receive weekly injections for a period of 52 weeks. The study will monitor changes in liver health, including improvements in liver fibrosis and the resolution of steatohepatitis, which is the inflammation of the liver due to fat accumulation.

Throughout the study, participants will be closely monitored to assess any changes in their liver condition and overall health. The study aims to provide valuable information on whether these medications can be an effective treatment option for people with NASH, potentially leading to better management of this liver disease. The trial is designed to ensure the safety and well-being of all participants while gathering important data on the effectiveness of the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical history related to non-alcoholic steatohepatitis (NASH).

  2. Step 2

    Initial assessment

    An initial assessment is conducted, which includes a liver biopsy to confirm the presence of NASH and determine the stage of liver fibrosis.

  3. Step 3

    Medication administration

    The study involves the administration of two medications: NNC0194-0499 and semaglutide. NNC0194-0499 is given at a dose of 30 mg once weekly, and semaglutide is given at a dose of 2.4 mg once weekly. Both medications are administered as a solution for injection under the skin (subcutaneous).

    A placebo may also be administered once weekly as part of the study design.

  4. Step 4

    Weekly follow-ups

    Weekly follow-up visits are scheduled to monitor the effects of the medication and assess any side effects. These visits continue for the duration of the study.

  5. Step 5

    Mid-study evaluation

    At the midpoint of the study, an evaluation is conducted to assess the progress of liver fibrosis and any changes in the condition of NASH.

  6. Step 6

    Final assessment

    At the end of the 52-week period, a final assessment is performed. This includes a repeat liver biopsy to evaluate changes in liver fibrosis and NASH.

    Additional tests may be conducted to measure changes in liver function and other health indicators.

  7. Step 7

    Completion of study

    Upon completion of the study, results are analyzed to determine the effectiveness of the medication combination in improving liver fibrosis and NASH.

Who can join the trial?

4 criteria

  • Must be at least 18 years old. In some countries, the minimum age is higher: 19 years in the Republic of Korea, 20 years in Japan, and 21 years in Singapore.
  • Must have **NASH** (Non-alcoholic steatohepatitis) confirmed by a liver biopsy, which is a small sample of liver tissue examined under a microscope. This biopsy can be from up to 180 days before the first visit.
  • Must have **fibrosis** (scarring of the liver) at stage 2, 3, or 4, as determined by a liver biopsy.
  • Must have a **NAFLD activity score** (a measure of liver disease activity) of 4 or more for those with fibrosis stage 2 or 3, or 3 or more for those with fibrosis stage 4. This score includes at least 1 point each for steatosis (fat in the liver), lobular inflammation (swelling in the liver), and hepatocyte ballooning (swelling of liver cells).

Who cannot join the trial?

4 criteria

  • Patients who have a different liver condition other than Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver disease that happens when fat builds up in the liver, causing inflammation and damage.
  • Patients who do not have liver fibrosis at stage 2 to 4 are excluded. Fibrosis is the thickening and scarring of tissue, and stages 2 to 4 indicate the severity of this condition in the liver.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, are not eligible.
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Investigated drugs

  • NNC0194-0499

    is an investigational medication being studied for its potential effects on liver fibrosis in patients with non-alcoholic steatohepatitis (NASH). It is administered once a week and is being tested to see how well it works in reducing liver damage when used alongside another medication.

  • Semaglutide

    is a medication that is already used for other health conditions, such as diabetes and weight management. In this trial, it is given once a week to see if it can help improve liver health in patients with NASH when used together with NNC0194-0499.

What is already known about the treatment

  • NNC0194-0499

    This medication is administered as an injection, typically given once a week. It is currently being studied in clinical trials for its effectiveness in treating non-alcoholic steatohepatitis (NASH), particularly in patients with advanced fibrosis. The drug works by targeting specific pathways involved in liver inflammation and fibrosis, aiming to reduce liver damage. It is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

  • Semaglutide

    Administered as a weekly injection, semaglutide is being evaluated in combination with NNC0194-0499 for its potential benefits in treating non-alcoholic steatohepatitis (NASH). It is already approved for other conditions, such as type 2 diabetes, and works by mimicking a hormone that regulates blood sugar levels and appetite. In the context of NASH, it may help reduce liver fat and inflammation. Semaglutide belongs to the class of medications known as GLP-1 receptor agonists.

Investigated diseases

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 liver fibrosis, where scar tissue forms in the liver, and potentially to cirrhosis, which is severe scarring that affects liver function. The disease often develops in individuals who are overweight or have diabetes, but it can occur in others as well. Symptoms may not be noticeable in the early stages, but as the disease progresses, it can lead to fatigue, weakness, and discomfort in the upper right abdomen. The progression of NASH can vary, with some individuals experiencing a slow progression and others developing more severe liver damage over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506961-74-00Protocol codeNN9500-4656Estimated enrolment698 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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