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RecruitingPhase 2

Tirzepatide for Alcohol Use Disorder

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

42

estimated

Study population

Alcohol / substance use, Obesity / overweight

Key I/E criterion

BMI ≥27

Primary endpoint

Number of heavy drinking days

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06994338
Org study IDHS-25-00273
Secondary ID1R21AA031892-01

Timeline

Milestones

Study first posted2025-05-29actual
Study start2025-10-06actual
Last update posted2025-10-14actual
Primary completion2026-08-31estimated
Study completion2026-08-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age21 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)

2. Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline

3. Body mass index ≥ 27kg/m2

4. Willingness to attend weekly medication visits and complete all study procedures

5. Ability to read and communicate in English

6. Age 21-65

7. Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)

8. Stable housing status

Exclusion criteria

1. Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)

2. 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.

3. 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.

4. Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment

5. History of chronic or acute pancreatitis

6. History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%

7. History of suicide attempt or report of current (past 2 weeks) active suicidal ideation

8. Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)

9. 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)

10. Treatment for eating disorder in the past 12 months

11. Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians

12. History of known liver disease

13. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (>3x upper limit of normal range)

14. History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer

15. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)

16. Weight loss > 5% in the 30 days prior to screening

17. Currently enrolled in another clinical trial involving an investigational product

18. Current contact or co-habitation with a current or former participant in the present trial

19. Current co-habitation with a person taking GLP-1RA therapy

20. Planned surgical procedures requiring anesthesia within 90 days post-entry into the study

21. History of treatment with tirzepatide or a GLP-1RA within 6 months of screening

22. 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

23. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I or type II

24. Estimated glomerular filtration rate (eGFR) <60 (indicated impaired kidney function)

25. Use of prescribed or non-prescribed medications that would preclude safe use of tirzepatide in the judgement of the study physicians

26. 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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

6 endpoints
Primary/protocol endpoint

Number of heavy drinking days

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

event count, improvement

Secondary/protocol endpoint

Drinks per drinking day

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

WHO drinking risk level

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

threshold achievement, improvement

Secondary/protocol endpoint

Abstinent days

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Absence of heavy drinking

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

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

Alcohol craving

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.