Alcohol Use Disorder (AUD)Phase 1SEMA AUDNCT07772960
Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
A Phase 1 study testing Semaglutide 1.0 mg and Semaglutide 2.0 mg in people with Alcohol Use Disorder (AUD) and Obesity (BMI Equal to or >30), run by Yale University at 2 sites in United States.
Trial summary
This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30)
- What is being tested?
- Semaglutide 1.0 mg and Semaglutide 2.0 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 31 Oct 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
- regular weekly alcohol use (at least 3X/week) prior to admission;
- must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
- Good health as verified by screening and physical examination;
- Able to read English and complete study evaluation;
- Able to provide informed written and verbal consent.
Who cannot join
- Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
- Current use of opiates;
- Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
- Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c >6.5% and on current medications for T2D treatment;
- Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;
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- Current use of any anti-obesity medications;
- Prior history of bariatric surgery or current intragastric balloon;
- Current participation in structured meal replacement or weight loss program;
- Weight loss of >=10% over the preceding 6 months;
- Women who are pregnant, nursing or refuse use of reliable form of birth control.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale Stress Center
New Haven, Connecticut, 06519
Karen Hunkele, BA, 888-978-7377, karen.hunkele@yale.edu
- Recruiting
Yale Stress Center
New Haven, Connecticut, 06519
Karen Hunkele, BA, 888-978-7377, rajita.sinha@yale.edu
About this study
This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
Read the detailed description
A randomized, double blind placebo controlled 20 week study of two doses of Semaglutide (SEMA) versus placebo in men and women with AUD and obesity (OB:BMI 30-49.9 kg/m2) will be studied to assess alcohol and food craving and stress in a validated laboratory model as well as examine changes in alcohol intake and related alcohol use outcomes during a 20 week clinical treatment and 8 week post-treatment follow-up phase of the study, in order to test mechanisms by which SEMA may exerts significant effects on alcohol use disorder outcomes.
- Being tested
- Placebo, Semaglutide 1.0 mg, Semaglutide 2.0 mg
- Keywords
- Alcohol Use Disorder, alcohol craving, Semaglutide, food craving, alcohol intake
- Medical subject headings
- Alcoholism, Obesity, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo - administered one weekly for 20 weeks
Semaglutide 1.0 mgDrug
Semaglutide 1.0 mg low dose
Semaglutide 2.0 mgDrug
Semaglutide 2.0 mg high dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo saline pen administered weekly for 20 weeks Receives: Other: Placebo |
| Semaglutide 1.0 mg | Active comparator | Semaglutide low dose of 1.0 mg administered weekly over the 20-weeks trial Receives: Drug: Semaglutide 1.0 mg |
| Semaglutide 2.0 mg | Active comparator | Semaglutide high dose 2.0 mg administered weekly over the 20-weeks trial Receives: Drug: Semaglutide 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use days
Days of alcohol use over 20 weeks of treatment
Measured: 20 weeks
Secondary outcomes (3)
Heavy drinking days
Days of heavy drinkings (Mne: greater than 5 or more drinks; Women: greater than 4 or more drinks)
Measured: 20 weeks
Average drinks per drinking day
Average number of alcoholic drinks consumed on a drinking day
Measured: 20 weeks
Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving
The OCDS is a 14-item self-report tool that measures alcohol craving, obsessive thoughts about drinking, and compulsive drinking behaviors. Total scores and subscale scores range from 0 to 40, with higher scores reflecting more overall craving in each category and total craving.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Oct 2026
- Primary completion31 Oct 2031 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Rajita Sinha, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772960
- Sponsor's protocol ID
- 2000042236
- Other IDs
- R01AA032779
- Acronym
- SEMA AUD
- Status last verified
- Nov 2026
- First submitted
- 13 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will follow NIH-NIAAA data sharing plan and upload de-identified individual data including demographics, treatment and outcomes data to the NIMHDataArchives (NDa) as required by NIAAA.
Publications
Harvanek ZM, Milivojevic V, Hart R, Sinha R. Alterations in glucose and insulin resistance following stress and alcohol cues predict alcohol craving in those with AUD and obesity: A preliminary study. Alcohol Clin Exp Res (Hoboken). 2026 May;50(5):e70283. doi: 10.1111/acer.70283.
PubMed 42101823
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
- ClinicalTrials.gov ID
- NCT07772960
- Acronym / sponsor ID
- SEMA AUD / 2000042236
- Keywords
- Alcohol Use Disorder, alcohol craving, Semaglutide, food craving, alcohol intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Oct 2031 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
Detailed description
A randomized, double blind placebo controlled 20 week study of two doses of Semaglutide (SEMA) versus placebo in men and women with AUD and obesity (OB:BMI 30-49.9 kg/m2) will be studied to assess alcohol and food craving and stress in a validated laboratory model as well as examine changes in alcohol intake and related alcohol use outcomes during a 20 week clinical treatment and 8 week post-treatment follow-up phase of the study, in order to test mechanisms by which SEMA may exerts significant effects on alcohol use disorder outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo saline pen administered weekly for 20 weeks |
| Semaglutide 1.0 mg | Active comparator | Drug: Semaglutide 1.0 mgSemaglutide low dose of 1.0 mg administered weekly over the 20-weeks trial |
| Semaglutide 2.0 mg | Active comparator | Drug: Semaglutide 2.0 mgSemaglutide high dose 2.0 mg administered weekly over the 20-weeks trial |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
- regular weekly alcohol use (at least 3X/week) prior to admission;
- must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
- Good health as verified by screening and physical examination;
- Able to read English and complete study evaluation;
Key exclusion criteria (11 listed)
- Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
- Current use of opiates;
- Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
- Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c >6.5% and on current medications for T2D treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo - administered one weekly for 20 weeks | Other | Placebo |
| Semaglutide 1.0 mgSemaglutide 1.0 mg low dose | Drug | Semaglutide 1.0 mg |
| Semaglutide 2.0 mgSemaglutide 2.0 mg high dose | Drug | Semaglutide 2.0 mg |
Primary outcome
Alcohol use days
Time frame: 20 weeks
Days of alcohol use over 20 weeks of treatment
3 secondary outcomes
Heavy drinking days
Time frame: 20 weeks
Average drinks per drinking day
Time frame: 20 weeks
Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 42101823Harvanek ZM, Milivojevic V, Hart R, Sinha R. Alterations in glucose and insulin resistance following stress and alcohol cues predict alcohol craving in those with AUD and obesity: A preliminary study. Alcohol Clin Exp Res (Hoboken). 2026 May;50(5):e70283. doi: 10.1111/acer.70283.
- Individual participant dataSharing planned: Yes. Investigators will follow NIH-NIAAA data sharing plan and upload de-identified individual data including demographics, treatment and outcomes data to the NIMHDataArchives (NDa) as required by NIAAA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajita Sinha principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide 1.0 mg and Semaglutide 2.0 mg in people with Alcohol Use Disorder (AUD) and Obesity (BMI Equal to or >30), run by Yale University at 2 sites 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RAJITA SINHA, PHD (2037375805, rajita.sinha@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use days (time frame: 20 weeks). 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 NCT07772960, which also lists 1 linked publication.
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 4 Nov 2026.