Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)

What Was Tested

This registered phase 2 trial tested Tirzepatide.

It had two arms (groups): Tirzepatide: subcutaneous administration of Tirzepatide plus CBT ("Take Control" program) (experimental) and Placebo: subcutaneous administration of placebo plus CBT ("Take Control" program) (placebo comparator).

The registry classes the interventions as behavioral, drug and other.

More on the Plan

Individuals with co-occurring AUD and overweight or obesity (AUD-OOB) are an underserved population with high relapse rates and elevated cardiometabolic risk.

The Edith Collins Centre (ECC) will serve as the coordinating centre.

The main question\[s\] it aims to answer are: 1.

These measures will assess changes in brain activity and autonomic responses to alcohol and food cues.

Who Took Part

The registry lists 46 planned participants were the target.

It was open to people of any sex aged from 21 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Able and willing to attend weekly clinic visits and complete all study procedures.

The full record lists 10 inclusion and 36 exclusion criteria; among the exclusions: 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 seizure, delirium tremens, or.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2026-01-15 with completion listed for 2027-05-15.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Heavy Drinking Days.

It also tracked 16 secondary outcomes, for example Number of drinks per drinking day consumed, Abstinent days, Alcohol Craving, WHO drinking risk level scale, Proportion of participants with zero heavy drinking days and Body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 46 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.