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

NCT06939088 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication tirzepatide can help reduce heavy drinking in adults who have both schizophrenia and alcohol use disorder.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 108 people Planned (estimated).

Who can join Ages 18–70 · all sexes

Timeline Started 2025-05 · est. completion 2028-12

Where 2 sites · Denmark

What this study is testing ClinicalTrials.gov NCT06939088 ↗

Description as written by the study sponsor.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide/GLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied. The key anticipated outcomes include: * decreased alcohol consumption and * reduced alcohol cue-induced brain activity in the GIP/GLP-1-treated patient group compared with the placebo group. To the best of the investigators knowledge, this has never been examined before.

Treatments tested

Tirzepatide also known as Mounjaro Drug

Once weekly injections s.c. with tirzepatide (Mounjaro(R))
Placebo also known as BD Posiflush (saline) Drug

Once weekly injections s.c. with placebo (BD Posiflush)

Main thing measured	Change in heavy drinking days
Sponsor	Anders Fink-Jensen, MD, DMSci
Conditions studied	Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06939088 ↗