Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Semaglutide's Effect on Reducing Alcohol Intake in Patients with Alcohol Use Disorder and Obesity

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 medication called semaglutide on individuals with Alcohol Use Disorder who also have obesity. Alcohol Use Disorder is a condition where a person has difficulty controlling their alcohol consumption, and obesity is when a person has an excessive amount of body fat. The medication being tested, semaglutide, is a type of drug known as a glucagon-like peptide 1 (GLP-1) receptor agonist, which is commonly used to help manage weight and blood sugar levels. In this study, semaglutide is being compared to a placebo, which is a substance with no active medication, to see if it can help reduce alcohol intake in people with these conditions.

The purpose of the study is to determine if semaglutide can effectively reduce the amount of alcohol consumed by participants over a period of 26 weeks. Participants will receive semaglutide or a placebo through an injection under the skin, using a pre-filled pen. The study will monitor changes in alcohol consumption, including the number of days participants drink heavily, the total amount of alcohol consumed, and the number of days without alcohol. Additionally, the study will observe changes in body weight, blood pressure, and other health indicators.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their health. The trial aims to provide valuable insights into whether semaglutide can be a beneficial treatment for reducing alcohol intake in individuals with Alcohol Use Disorder and obesity. The study is expected to conclude in 2026, with results helping to inform future treatment options for these conditions.

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

    Joining the study

    Upon joining the study, you will be asked to provide informed oral and written consent. This means you agree to participate after understanding the study's purpose and procedures.

    You must meet certain criteria, such as being diagnosed with alcohol use disorder and having a body mass index (BMI) of 30 or higher. Your age should be between 18 and 70 years.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status and alcohol consumption patterns. This includes measuring your alcohol intake over the past 30 days.

    Your alcohol consumption will be assessed using the Timeline Followback (TLFB) method, which involves recalling your drinking habits over a specified period.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the medication semaglutide through a subcutaneous injection. This means the medication is injected under the skin.

    The dosage of semaglutide will be gradually increased to a maximum of 2.4 mg, administered once a week, over a period of 26 weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your alcohol consumption and health parameters will be regularly monitored. This includes changes in your drinking habits, body weight, and other health indicators.

    You will be asked to attend regular follow-up visits to assess your progress and any changes in your condition.

  5. Step 5

    End of study evaluation

    At the end of the 26-week treatment period, a final evaluation will be conducted to measure the changes in your alcohol consumption and overall health.

    The study aims to determine if semaglutide effectively reduces alcohol intake in individuals with alcohol use disorder and obesity.

Who can join the trial?

6 criteria

  • Provide informed consent, which means you agree to participate after understanding the study details, both orally and in writing.
  • Have a diagnosis of alcohol dependence according to the International Classification of Diseases 10 (ICD-10) and alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  • Have an Alcohol Use Disorder Identification Test (AUDIT) score greater than 15. This is a questionnaire that helps identify alcohol use problems.
  • Have a Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
  • Be between the ages of 18 and 70, inclusive.
  • Engage in heavy alcohol drinking, defined as drinking more than 6 days with alcohol consumption over 4 units (48 grams of alcohol) for women and 5 units (60 grams of alcohol) for men during a consecutive 30-day period, within 40 days before the start of the study. This is measured by the Timeline Followback (TLFB) method, which is a way to track alcohol consumption over time.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Alcohol Use Disorder cannot participate.
  • Patients who do not have comorbid obesity (obesity occurring alongside another condition) cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Semaglutide is a medication that is being studied to see if it can help reduce alcohol intake in people who have Alcohol Use Disorder and are also dealing with obesity. It works by mimicking a natural hormone in the body that helps control appetite and blood sugar levels. Researchers are interested in finding out if this medication can also help people drink less alcohol by affecting the brain areas that control cravings and addiction.

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 potential to help reduce alcohol intake in people with Alcohol Use Disorder who also have obesity. The main therapeutic indication being explored is its ability to decrease alcohol consumption. At the molecular level, semaglutide works by mimicking a natural hormone in the body 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 commonly used to treat type 2 diabetes and obesity.

Investigated diseases

Alcohol Use Disorder – Alcohol Use Disorder is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It often begins with occasional drinking that gradually increases in frequency and quantity. Over time, individuals may develop a tolerance, requiring more alcohol to achieve the same effects. As the disorder progresses, individuals may experience withdrawal symptoms when not drinking. The condition can lead to significant disruptions in daily life, affecting relationships, work, and overall health. It is a chronic condition that can vary in severity, with some individuals experiencing periods of remission and relapse.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503371-25-00Estimated enrolment108 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).