Tirzepatide for Alcohol Use Disorder

Q: What is the NCT06994338 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT06994338?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06994338?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Tirzepatide for Alcohol Use Disorder (NCT06994338) is a Phase 2 interventional studying Alcohol Use Disorder and Obesity and Overweight, sponsored by University of Southern California. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Alcohol Use Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 42 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Tirzepatide

Tirzepatide injections (2.5mg, 5.0mg)

DRUG

Placebo injections

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Keck School of Medicine, University of Southern California

Los Angeles, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06994338), the sponsor (University of Southern California), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06994338 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06994338?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06994338?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06994338. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06994338. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.