Could a diabetes shot curb heavy drinking? new trial aims to find out
NCT ID NCT07292519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a weekly injection of tirzepatide (a diabetes drug) plus cognitive-behavioral therapy can help adults with alcohol use disorder and overweight or obesity reduce heavy drinking days. 46 participants will receive either the drug or a placebo shot for 8 weeks, along with counseling. The goal is to see if the combination cuts down on heavy drinking and improves health measures like weight and blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 21 to 75 years 2. Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year) 3. Have an average daily alcohol consumption of: * ≥60g ethanol/day for men * ≥40g ethanol/day for women (based on the 28 days prior to the baseline visit) 4. Body mass index (BMI) ≥27 kg/m² 5. Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment 6. Able and willing to attend weekly clinic visits and complete all study procedures 7. Fluent in English and able to provide informed consent 8. Stable housing situation (not transient or homeless) Exclusion Criteria: 1. Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder) 2. Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances 3. History of significant alcohol withdrawal, defined by: * History of seizure, delirium tremens, or * Hospitalisation for withdrawal, or * CIWA-Ar score \>9, or * PAWS score \>4 at screening 4. Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months 5. History or current diagnosis of: * Type 1 or Type 2 diabetes * Diabetic complications (e.g. retinopathy) * HbA1c ≥6.5% at screening 6. Significant psychiatric illness, including: * Current active suicidal ideation (per C-SSRS) * Lifetime history of psychosis or bipolar disorder * Unstable depression or anxiety interfering with daily functioning 7. Chronic or acute pancreatitis 8. Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin \>3× ULN) 9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I/II 10. Estimated glomerular filtration rate (eGFR) \<30 mL/min 11. Recent significant weight loss (\>5% of body weight in past 30 days) 12. Use of any weight loss medication (e.g., orlistat, bupropion-naltrexone) or AUD medication (e.g., naltrexone, acamprosate, topiramate, varenicline) in the past 3 months 13. Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months 14. Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential) 15. Inability to attend weekly visits due to work/travel/schedule conflicts 16. Participation in another clinical trial involving an investigational product 17. Shared household with a current or past participant in this trial 18. Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up 19. History of muscle wasting, bone disorders (e.g. sarcopenia) 20. Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD) 21. Uncontrolled hypertension, recent heart attack or stroke (within 6 months) Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging \& Psychophysiology Tasks: 22. Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants 23. History of brain surgery or penetrating head trauma 24. Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments) 25. Non-removable piercings or dental hardware that would interfere with MRI 26. History of claustrophobia likely to interfere with scanning compliance aa. Neurological disorders (e.g., epilepsy, multiple sclerosis) likely to confound neuroimaging data bb. Inability to lie still or tolerate MRI procedures cc. Patient weighting over 159kg (MRI scan limit) dd. Any other condition or medication judged by the investigator to preclude safe participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
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