Status and phase
Conditions
Treatments
About
The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight/obesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.
Full description
Individuals with co-occurring AUD and overweight or obesity (AUD-OOB) are an underserved population with high relapse rates and elevated cardiometabolic risk. Recent evidence suggests that Tirzepatide can simultaneously reduce alcohol intake in animal models and craving, drinks per day and heaving drinking days over a 9-week period in non-treatment seeking individuals with AUD. Tirzepatide's dual incretin mechanism offers the potential to simultaneously reduce alcohol use and improve metabolic health in this group, with a favourable safety profile and weekly dosing that supports adherence. As rates of AUD and obesity continue to rise, identifying pharmacological strategies that can address both conditions concurrently is a high public health priority.
This is a phase II, randomised, double-blind, placebo-controlled clinical trial of 46 individuals designed to evaluate the effects of Tirzepatide on alcohol consumption, craving and cardiometabolic outcomes in adults with alcohol used disorder and overweight/obesity (AUD-OOB), to receive either a sub-cutaneous injection of tirzepatide (n=23) or a visually matched placebo (n=23).
The trial will be conducted at a single clinical site in New South Wales, Australia. The Edith Collins Centre (ECC) will serve as the coordinating centre.
In summary participants will:
The primary aim of this clinical trial is to examine the effects of weekly tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) versus placebo injections, in combination with a structured behavioural intervention (Take Control) on alcohol consumption in adults with alcohol use disorder and overweight/obesity (AUD-OOB). The main question[s] it aims to answer are:
Main outcome: To determine the efficacy of Tirzepatide on alcohol related outcomes, the change in the number of heavy drinking days during the final four weeks of treatment (week 5 - 8, with a final assessment at week 9) will be assessed by comparison with baseline (28 days prior to baseline visit). Researchers will compare tirzepatide to placebo injections (a look-alike substance that contains no drug) to see if weekly tirzepatide administration can reduce the number of heavy drinking days.
Secondary Outcomes:
i) To evaluate changes in additional alcohol-related outcomes:
ii) To evaluate changes in cardiometabolic indices from baseline to Week 9:
iii) To assess safety outcomes associated the delivery of Tirzepatide, investigators will measure the:
Participants will complete additional neurobiological assessments including functional magnetic resonance imaging (fMRI) and laboratory-based psychophysiology at two timepoints: baseline (pre-treatment) and the final treatment visit (Week 8), which coincides with the final tirzepatide/placebo dose and final Take Control session. These measures will assess changes in brain activity and autonomic responses to alcohol and food cues.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Aged 21 to 75 years
Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year)
Have an average daily alcohol consumption of:
Body mass index (BMI) ≥27 kg/m²
Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment
Able and willing to attend weekly clinic visits and complete all study procedures
Fluent in English and able to provide informed consent
Stable housing situation (not transient or homeless)
Exclusion criteria
Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder)
Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances
History of significant alcohol withdrawal, defined by:
Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months
History or current diagnosis of:
Significant psychiatric illness, including:
Chronic or acute pancreatitis
Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin >3× ULN)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I/II
Estimated glomerular filtration rate (eGFR) <30 mL/min
Recent significant weight loss (>5% of body weight in past 30 days)
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
Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months
Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential)
Inability to attend weekly visits due to work/travel/schedule conflicts
Participation in another clinical trial involving an investigational product
Shared household with a current or past participant in this trial
Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up
History of muscle wasting, bone disorders (e.g. sarcopenia)
Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD)
Uncontrolled hypertension, recent heart attack or stroke (within 6 months)
Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging & Psychophysiology Tasks:
Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants
History of brain surgery or penetrating head trauma
Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments)
Non-removable piercings or dental hardware that would interfere with MRI
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
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Kirsten C Morley, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal