AzTrials
AzTrials

Alcohol Use DisorderPhase 2NCT06994338

Tirzepatide for Alcohol Use Disorder

A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder and Obesity and Overweight, run by University of Southern California at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity. Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited States
Study dates
6 Oct 2025to 31 Aug 2026
Phase
Phase 2
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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
  • Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
  • Body mass index ≥ 27kg/m2
  • Willingness to attend weekly medication visits and complete all study procedures
  • Ability to read and communicate in English
  • Age 21-65
  • Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
  • Stable housing status

Who cannot join

  • Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
  • Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.
  • History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related symptoms; a CIWA score >9 at assessment; or a baseline score 4+ on the Prediction of Alcohol Withdrawal Severity (PAWS) scale.
  • Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
  • History of chronic or acute pancreatitis
  • History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%
Show all 27Show fewer
  • History of suicide attempt or report of current (past 2 weeks) active suicidal ideation
  • Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)
  • Evidence of a significant anxiety or depressive disorder that is currently interfering with daily functioning, based on GAD-7 and PHQ-9 scores and physician judgement. (Anxiety or depression are not exclusionary if symptoms are stable/non-interfering with daily activities, or if the participant is receiving treatment, i.e., psychiatric medications have not changed for at least 3 months prior to baseline)
  • Treatment for eating disorder in the past 12 months
  • Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians
  • History of known liver disease
  • Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (>3x upper limit of normal range)
  • History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer
  • Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
  • Weight loss > 5% in the 30 days prior to screening
  • Currently enrolled in another clinical trial involving an investigational product
  • Current contact or co-habitation with a current or former participant in the present trial
  • Current co-habitation with a person taking GLP-1RA therapy
  • Planned surgical procedures requiring anesthesia within 90 days post-entry into the study
  • History of treatment with tirzepatide or a GLP-1RA within 6 months of screening
  • Treatment with any weight loss medications (e.g., orlistat, bupropion-naltrexone) or medications known to reduce alcohol consumption (e.g., naltrexone, topiramate, acamprosate, varenicline) in the past 3 months
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I or type II
  • Estimated glomerular filtration rate (eGFR) <60 (indicated impaired kidney function)
  • Use of prescribed or non-prescribed medications that would preclude safe use of tirzepatide in the judgement of the study physicians
  • Known bone, muscle, or wasting conditions (e.g., osteoporosis, sarcopenia) aa. Presence of significant or uncontrolled GI conditions (e.g., GERD) that would interfere with treatment in the judgement of study physicians bb. Any other significant disease, disorder, or finding that in the opinion of the investigator(s) may increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • cc. Currently pregnant or nursing, or inability to adhere to a reliable method of birth control (applies to female participants of childbearing age) dd. Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of >180/110 after three successive readings ee. History of heart attack or stroke in the 6 months prior to screening ff. A pre-treatment reduction in alcohol consumption to < 40g/day (males) or <20g/day (females) in the interval between baseline screening and randomization

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christian Hendershot, Ph.D. contact

(323) 442-1082

christian.hendershot@usc.edu

United States1 site, 1 recruiting

  • Keck School of Medicine, University of Southern California

    Los Angeles, California, 90032

    Tom Gilmore, 2139620698, thomas.gilmore@usc.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase II Evaluation of Tirzepatide in Adults With Alcohol Use Disorder and Overweight or Obesity

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.

Being tested
Tirzepatide, Placebo injections
Keywords
Tirzepatide, GLP-1, Addiction, Alcohol
Medical subject headings
Alcoholism, Obesity, Overweight, Behavior, Addictive

What participants receive

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

  • TirzepatideDrug

    Tirzepatide injections (2.5mg, 5.0mg)

  • Placebo injectionsDrug

    Placebo injections

Study groups in NCT06994338
Study groupRoleWhat they receive
TirzepatideExperimentalNot described
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo injections

What is being measured

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

  1. Number of heavy drinking days

    Number of heavy drinking days (NHDD) during the last four weeks of treatment (treatment Weeks 5-8), as measured by the Timeline Followback interview. NHDD is defined as the total number of days on which participants consumed 5 or more drinks (for men) or 4 or more drinks (for women). The analysis of NHDD will control for baseline NHDD (defined as NHDD in the four weeks preceding treatment).

    Measured: Last 4 weeks of treatment (Weeks 5-8)

Secondary outcomes (5)

  1. Drinks per drinking day

    Drinks per drinking day (DDD) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. DDD is defined as average number of drinks consumed on drinking days. The analysis will control for baseline DDD (defined as DDD in the four weeks preceding treatment).

    Measured: Last 4 weeks of treatment (Weeks 5-8)

  2. WHO drinking risk level

    WHO risk level is determined based on average grams of daily alcohol consumption, as measured by the Timeline Followback interview. WHO drinking risk level will be measured on a scale from 0-4 (corresponding to abstinence, low, moderate, high, or very high risk). The proportion of participants with a 1-level and 2-level reduction in WHO risk level between baseline (defined as the 28 days prior to the baseline visit) and the final month of treatment (Weeks 5-8) will be computed.

    Measured: Last 4 weeks of treatment (Weeks 5-8)

  3. Abstinent days

    Abstinent days (proportion of days on which no alcohol consumption is reported) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. The analysis will control for baseline (defined as proportion of abstinent days in the four weeks preceding treatment).

    Measured: Last 4 weeks of treatment (Weeks 5-8)

  4. Absence of heavy drinking

    Absence/remission of heavy drinking in the last month of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. Heavy drinking days are defined as consuming 5 or more drinks (for men) or 4 or more drinks (for women). The change in the proportion of participants with zero heavy drinking days from baseline (defined as the four weeks preceding treatment) to the Weeks 5-8 will be compared across treatment groups.

    Measured: Last 4 weeks of treatment (Weeks 5-8)

  5. Alcohol craving

    Alcohol craving is measured with the Penn Alcohol Craving Scale (PACS, range: 0-30). Intervention group differences in average weekly craving for the last month of treatment (Weeks 5-8) will be compared. This analysis will control for participants' baseline craving (defined as PACS score assessed at Week 1 prior to the first medication dose).

    Measured: Last 4 weeks of treatment (Weeks 5-8)

Timeline

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

  1. First posted29 May 2025
  2. Study start6 Oct 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06994338
Sponsor's protocol ID
HS-25-00273
Other IDs
1R21AA031892-01
Status last verified
Oct 2025
First submitted
16 May 2025
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder and Obesity and Overweight, run by University of Southern California 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 8 inclusion and 27 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 14 Oct 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?

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 Christian Hendershot, Ph.D. ((323) 442-1082, christian.hendershot@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of heavy drinking days (time frame: Last 4 weeks of treatment (Weeks 5-8)). 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 NCT06994338.

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 14 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in