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

NCT06939088 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Use Disorder
  • Alcohol Abuse/Dependence
  • Alcohol Dependence
  • Alcoholism
  • Schizophrenia Disorders
  • Schizophrenia and Disorders With Psychotic Features
  • Schizophrenia and Schizophrenia Spectrum Psychosis
  • Schizophrenia

Interventions

DRUG

Tirzepatide

Once weekly injections s.c. with tirzepatide (Mounjaro(R))

DRUG

Placebo

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

Sponsors & Collaborators

  • Anders Fink-Jensen, MD, DMSci

    lead OTHER

Principal Investigators

  • Anders Fink-Jensen, MD, DMSc, Professor · Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2028-08-01
Completion
2028-12-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939088 on ClinicalTrials.gov