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Alcohol Use DisorderPhase 2NCT05892432

Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

A Phase 2 study testing Semaglutide 3 MG [Rybelsus] and Semaglutide 7 MG [Rybelsus] in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Semaglutide 3 MG [Rybelsus] and Semaglutide 7 MG [Rybelsus]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
11 Jan 2024to 15 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21 or older.
  • Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current AUD of at least moderate severity, as assessed by the Mini International Neuropsychiatric Interview (MINI).
  • Seeking pharmacological treatment for AUD and wants to stop or cut down on drinking.
  • Has a body mass index (BMI) of at least 25 kg/m2.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site.
  • Please contact clinical site for additional inclusion criteria.

Who cannot join

  • Current DSM-5 diagnosis of any other substance use disorder of moderate or greater severity, except for Nicotine Use Disorder, as assessed by MINI.
  • Urine drug screen at screening positive for any substance except cannabis.
  • Current DSM-5 bipolar disorder, major depressive episode, or panic disorder, as assessed by MINI.
  • Current or lifetime eating disorder (anorexia, bulimia, or binge eating disorder) or psychotic disorder, as assessed by MINI.
  • Current suicidal ideation or homicidal ideation.
  • Current use of other psychotropic medications except antidepressants (for which dose must be stable for at least the past 2 months).
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  • Current or past-month use of AUD pharmacotherapy, including (e.g., oral naltrexone, acamprosate, or disulfiram) or current or past 60-day use of injectable naltrexone.
  • Current psychotherapy in which the primary focus is AUD. Attendance at Alcoholics Anonymous (AA) meetings is not exclusionary.
  • Current or past-month use of weight control medications.
  • Current or past-month use of metformin for any indication.
  • Any prior use of semaglutide or other GLP-1 agonists.
  • History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self- report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
  • Current or lifetime Type 1 or Type 2 diabetes diagnosis, or HbA1c >6.5%.
  • Current or lifetime kidney disease or creatinine clearance <80 mL/min for participants <=55 years of age (<65 mL/min for those >55).
  • Personal history of gastrointestinal disease (e.g., gastroparesis) or pancreatitis.
  • Personal or family history of medullary thyroid carcinoma and/or multiple endocrine neoplasia syndrome type 2
  • Current or past hepatocellular disease, as indicated by verbal report or elevations of serum amylase, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range at screening.
  • Uncontrolled hypertension (systolic BP >160 mmHg or diastolic >100 mmHg).
  • Biological females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception.
  • Lack of a stable living situation.
  • (If participating in MRI sessions) Contraindications to MRI scanning, ferrous metal in the body including intracranial, intraorbital, or intraspinal metal, pacemakers, cochlear implants, other non-MRI-compatible devices, or other devices that could compromise the quality of the MRI images such as a permanent top retainer or braces.
  • (If participating in MRI sessions) Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Randomized, Controlled Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects, relative to placebo, on alcohol cue-elicited craving and alcohol consumption.

Read the detailed description

A screening visit will be conducted at which written informed consent will be obtained and inclusion/exclusion criteria will be assessed. Subsequently, eligible participants will be randomly assigned to take oral semaglutide or matched placebo for 8 weeks, with the semaglutide dose titrated from 3 milligrams (mg)/day for the first 4 weeks to 7 milligrams (mg)/day for the second 4 weeks. Participants will complete 7 additional clinic visits (weekly during the first 4 weeks of the treatment period and biweekly during the second 4 weeks). At each visit, participants will also engage in a computerized behavioral intervention. At screening and again at the Week 6 visit, participants will complete an alcohol cue reactivity task. At the Week 1 visit, before ingesting the first dose of study medication, and again at the Week 8 visit, participants will complete a functional MRI session.

Being tested
Semaglutide 3 MG [Rybelsus], Semaglutide 7 MG [Rybelsus], Placebo
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide 3 MG [Rybelsus]Drug

    Also called Rybelsus 3 mg

    Semaglutide 3 mg will be taken for the first 4 weeks of the 8-week trial.

  • Semaglutide 7 MG [Rybelsus]Drug

    Also called Rybelsus 7 mg

    Semaglutide 7 mg will be taken for the second 4 weeks of the 8-week trial.

  • PlaceboDrug

    A medically inert placebo medication will be taken for 8 weeks.

Study groups in NCT05892432
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
Receives: Drug: Placebo
Semaglutide 3 milligrams and 7 milligramsActive comparatorParticipants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
Receives: Drug: Semaglutide 3 MG [Rybelsus]; Drug: Semaglutide 7 MG [Rybelsus]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cue Craving Visual Analog Score

    The primary efficacy endpoint will be the magnitude of change between screening and Week 6 in the cue-craving VAS score on the first VAS item ("How strong is your craving to drink alcohol?") administered after the alcohol cue presentation. Scores range from 0 (none) to 20 (extremely strong). Higher scores indicate a higher level of craving.

    Measured: 7 weeks - change between screening and Week 6 visit

Secondary outcomes (3)

  1. Number of drinks per day

    The number of standard alcoholic drinks participants consume per day during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.

    Measured: 4 weeks

  2. Percentage of heavy drinking days

    The percentage of heavy drinking days during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.

    Measured: 4 weeks

  3. Change in alcohol cue-elicited brain activation

    Change in fMRI BOLD activation to alcohol vs. neutral beverage visual cues between baseline and Week 8.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start11 Jan 2024
  3. Primary completion4 Nov 2025
  4. Study completion15 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Double-blind placebo controlled clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05892432
Sponsor's protocol ID
23-0261
Other IDs
R21AA031146
Status last verified
Dec 2025
First submitted
26 May 2023
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified, individual-level phenotypic data will be submitted to the NIAAA Data Archive (NDA) portal once it is available. Informed consent that allows for broad sharing of each subject\&#39;s de-identified data will be obtained and personally identifiable information that allows the creation of an NDA Global Unique Identifier will be collected. The PI and study staff will work with NDA staff to specify and/or define measures to be collected, and data will be submitted in accordance with NDA submission due dates.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide 3 MG [Rybelsus] and Semaglutide 7 MG [Rybelsus] in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cue Craving Visual Analog Score (time frame: 7 weeks - change between screening and Week 6 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05892432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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