Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

What Was Tested

This registered phase 2 trial tested Tirzepatide.

To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Saline s.c. once-weekly.

The registry classes the interventions as drug.

More on the Plan

The primary endpoint will be evaluated after 16 weeks of treatment.

Alcohol consumption and secondary endpoints will be assessed at weeks 0, 4, 8, 12, 16, 20, 26, and 40, and all patients will be offered 6 sessions of supportive therapy, while participating in the study.

The randomisation and administration of the weekly injections (tirzepatide/placebo) will be administered by an unblinded staff not involved in other trial activities.

All patients will be blindfolded when receiving the injections.

Who Took Part

The registry lists 108 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Informed Consent: The patient must provide both oral and written informed consent. Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5. AUDIT Score: Alcohol Use Disorder Identification Test (AUDIT) score greater than 15. Body Mass Index (BMI): BMI of 23 kg/m² or higher. Age Range: Between 18 and 70 years old (inclusive).

The full record lists 8 inclusion and 23 exclusion criteria; among the exclusions: intellectual disability: individuals with a diagnosis of intellectual disability; acute psychosis: acute exacerbation of psychosis, as indicated by a score of 6 or 7 on the clinical global impression-severity (cgi-s) scale; coercive measures: current use of coercive measures, which includes individuals sentenced to treatment ('dom til behandling').

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2025-05-05 with completion listed for 2028-08-01.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in heavy drinking days (time frame: From baseline to 16 weeks of treatment).

It also tracked 28 secondary outcomes, for example Heavy drinking days, Total alcohol consumption, Days without alcohol consumption, World Health Organization (WHO) Risk Levels of Alcohol Consumption, Penn Alcohol Craving Scale (PACS) score and Alcohol Use Disorder Identification Test (AUDIT) score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 108 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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