If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Phase 2 study for people with Obesity
Not yet recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Drug Health Services, Royal Prince Alfred Hospital | Sydney | NSW | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 18 December 2025.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.