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A study testing NNC0194-0499, cagrilintide, and semaglutide alone or combined to treat liver damage in people with alcohol-related liver disease

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What is this trial about?

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

This study is looking at alcohol-related liver disease, which is damage to the liver caused by long-term heavy alcohol use. The liver is an organ that helps clean the blood and perform many important body functions, and excessive alcohol consumption over time can cause scarring and inflammation of the liver tissue. The study will test several medications given as injections under the skin. These include zalfermin (also known as NNC0194-0499), cagrilintide, and semaglutide. Some participants will receive these medications alone, while others will receive combinations of cagrilintide with semaglutide or zalfermin with semaglutide. Some participants will receive placebo. The purpose of the study is to find out if these medications, used alone or in combination, can reduce liver damage and improve liver function in people with alcohol-related liver disease, and also to see if they affect alcohol use.

During the study, participants will receive their assigned treatment for up to 28 weeks. The study will measure changes in the liver by looking at specific markers in the blood that show liver scarring and damage, such as the Enhanced Liver Fibrosis score and other substances that indicate how much scar tissue is forming in the liver. The study will also use a special ultrasound device that measures liver stiffness and fat content by sending gentle vibrations through the liver. Blood tests will check liver enzymes, which are proteins released when liver cells are damaged, and cholesterol levels. To understand effects on alcohol use, the study will measure a substance in the blood called phosphatidylethanol that indicates recent alcohol consumption, and participants will report their alcohol intake over time. The study will also carefully monitor any side effects that occur during treatment.

Participants in this study must be adults who have a history of drinking significant amounts of alcohol regularly for at least five years and who have evidence of liver damage based on blood test results. The study will compare how well the different medications work by measuring changes in liver health markers and alcohol use from the beginning to the end of the treatment period.

The research process

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

  1. Step 1

    Treatment period

    During the study, you will receive one of several treatment options. The treatment will be administered as an injection under the skin (subcutaneous injection).

    The possible treatments include: cagrilintide alone, semaglutide alone, cagrilintide combined with semaglutide, zalfermin, or placebo (an inactive substance that looks like the medication but contains no active ingredients).

    All medications are provided as solution for injection.

    The specific dosage, frequency, and duration of your treatment will be determined by the study protocol, but these details are not specified in the available information.

  2. Step 2

    Monitoring of liver condition

    Throughout the study, your liver condition will be monitored using several methods.

    Blood tests will be performed to measure Enhanced Liver Fibrosis (ELF), which is a marker that indicates the level of scarring in your liver.

    Additional blood tests will measure Pro-peptide of Collagen 3 (Pro-C3), which is another marker related to liver scarring.

    Your liver will also be assessed using Vibration Controlled Transient Elastography (VCTE), a non-invasive test that measures liver stiffness.

    Controlled Attenuated Parameter (CAP) will be used to measure the amount of fat in your liver.

    Blood tests will check levels of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST), which are enzymes that indicate liver function.

    Your total cholesterol levels will also be measured.

  3. Step 3

    Monitoring of alcohol use

    Your alcohol consumption will be monitored during the study.

    Blood tests will measure Phosphatidylethanol (PEth), which is a substance that indicates recent alcohol use.

    You will be asked to complete a timeline follow-back (TLFB), which is a method where you report the amount of alcohol you have consumed over a specific period.

  4. Step 4

    Safety monitoring

    Throughout the study, any side effects or health changes you experience will be recorded and monitored.

    These are referred to as treatment-emergent adverse events, which means any unwanted medical occurrences that happen during your treatment period.

Who can join the trial?

5 criteria

  • You must provide informed consent, which means you agree to participate in the study after understanding all the details, before any study activities begin
  • You can be male or female
  • You must be 18 years old or older and at the legal age for drinking alcohol in your area
  • You must have a history of drinking too much alcohol for at least 5 years, with an average of at least 50 grams of alcohol per day for men or 40 grams of alcohol per day for women during the past year
  • You must have an ELF score of 9.0 units or higher, which is a blood test that measures liver scarring and damage

Who cannot join the trial?

3 criteria

  • The study document does not list specific reasons why patients cannot participate in this trial
  • If you are interested in this study, a doctor will need to check if you meet all the requirements during a screening visit
  • General safety checks will be performed to make sure the study is appropriate for you
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Investigated drugs

  • NNC0194-0499

    is an investigational medication being tested in this trial. It is being studied both on its own and when combined with semaglutide to see if it can help reduce liver damage and improve liver function in people with alcohol-related liver disease.

  • Semaglutide

    is a medication that is being tested in this trial both on its own and in combination with other medications. It is being studied to see if it can help reduce liver damage and improve liver function in people with alcohol-related liver disease.

  • Cagrilintide

    is a medication being tested in this trial. It is being studied both on its own and when combined with semaglutide to see if it can help reduce liver damage and improve liver function in people with alcohol-related liver disease.

What is already known about the treatment

  • NNC0194-0499

    This is an experimental medication currently being studied in clinical trials for the treatment of alcohol-related liver disease. It is being tested both as a single treatment and in combination with semaglutide to evaluate its effects on liver damage and function. The specific form of administration and exact mechanism of action have not been publicly disclosed as the drug is still under investigation. This substance aims to help reduce liver damage in patients suffering from alcohol-related liver disease.

  • Semaglutide

    This medication is administered as an injection under the skin and is already approved for treating type 2 diabetes and obesity by helping to control blood sugar levels and reduce appetite. In this clinical trial, it is being studied for a new purpose: treating alcohol-related liver disease, both alone and in combination with experimental drugs. Semaglutide works by mimicking a natural hormone called GLP-1, which helps regulate insulin release, slows down digestion, and reduces food intake.

  • Cagrilintide

    This is an injectable medication currently under investigation that mimics a natural hormone called amylin, which helps control appetite and food intake. It is being tested in this clinical trial for its potential to treat alcohol-related liver disease, both as a single treatment and in combination with semaglutide. The drug works at the molecular level by activating amylin receptors in the brain, which can help reduce food consumption and may have beneficial effects on liver function and alcohol use.

Investigated diseases

Alcohol-related liver disease – Alcohol-related liver disease is a condition that develops when the liver becomes damaged due to excessive alcohol consumption over time. The disease progresses through several stages, starting with the accumulation of fat in liver cells, known as fatty liver. If drinking continues, inflammation of the liver tissue occurs, which can lead to the destruction of liver cells. As the disease advances, healthy liver tissue is gradually replaced by scar tissue, a process called fibrosis. In more severe cases, extensive scarring throughout the liver develops, significantly affecting the liver's ability to function properly. The progression of the disease depends on the amount and duration of alcohol consumption, as well as individual factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508170-28-00Protocol codeNN9500-7730Estimated enrolment287 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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