NCT06939088

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
33mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
May 2025Dec 2028

First Submitted

Initial submission to the registry

April 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

April 14, 2025

Last Update Submit

February 5, 2026

Conditions

Alcohol Use DisorderAlcohol Abuse/DependenceAlcohol DependenceAlcoholismSchizophrenia DisordersSchizophrenia and Disorders With Psychotic FeaturesSchizophrenia and Schizophrenia Spectrum PsychosisSchizophrenia

Keywords

GLP-1Glucagon-like peptide 1fMRIGIPGlucose-dependent Insulinotropic PolypeptideTirzepatideMounjaro(R)schizophreniaalcoholalcohol use disorderdual diagnosis

Outcome Measures

Primary Outcomes (1)

  • Change in heavy drinking days

    The primary endpoint will be a change in alcohol consumption, measured as a per cent change in heavy drinking days after 16 weeks of treatment with tirzepatide or placebo, adjusted for the value at baseline (percentage points). Heavy drinking days will be registered using the Timeline-Follow-Back (TLFB) method including the last 21 consecutive days with the largest total alcohol intake and the greatest number of heavy drinking days within the 28 days preceding the evaluation. A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day.

    From baseline to 16 weeks of treatment

Secondary Outcomes (28)

  • Heavy drinking days

    From baseline to 26 weeks of treatment and 14 weeks post-intervention

  • Total alcohol consumption

    From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

  • Days without alcohol consumption

    From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

  • World Health Organization (WHO) Risk Levels of Alcohol Consumption

    From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

  • Penn Alcohol Craving Scale (PACS) score

    From baseline to 16 and 26 weeks of treatment

  • +23 more secondary outcomes

Other Outcomes (1)

  • Safety Outcome

    From baseline to 16 and 26 weeks of treatment

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Tirzepatide once-weekly s.c.titrated to a maximum dose of 15 mg

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Saline s.c. once-weekly

Drug: Placebo

Interventions

TirzepatideDRUG

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

Also known as: Mounjaro
Tirzepatide
PlaceboDRUG

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

Also known as: BD Posiflush (saline)
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent: The patient must provide both oral and written informed consent.
  • Diagnosis:
  • Diagnosed with alcohol dependence according to the International Classification of Diseases, 10th Edition (ICD-10), and alcohol use disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  • 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).
  • Heavy Alcohol Consumption: Defined as 4 or more heavy drinking days within a consecutive 21-day period during the 28 days preceding the baseline evaluation. The 21-day period will be selected based on the largest total alcohol consumption and the greatest number of heavy drinking days within the 28-day timeframe. This will be assessed using the Timeline Followback (TLFB) method. Heavy drinking days are defined as days with an alcohol intake of 4 or more units (48 g of alcohol) for women and 5 or more units (60 g of alcohol) for men.

You may not qualify if:

  • 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').
  • Suicidal Behaviour: Evidence of current severe suicidal behaviour, as assessed by the investigator during clinical evaluation.
  • History of Severe Alcohol Withdrawal: History of delirium tremens or alcohol withdrawal seizures.
  • Severe Withdrawal Symptoms: Clinical Institute Withdrawal Assessment of Alcohol Scale, revised (CIWA-Ar) score greater than 9 at baseline examination.
  • Severe Neurological Conditions: Presence of severe neurological diseases, including severe traumatic brain injury.
  • Diabetes: Type 1 or 2 diabetes
  • Liver Function: Impaired hepatic function, defined as liver transaminases greater than three times the upper limit of normal.
  • Renal Function: Impaired renal function, indicated by an estimated glomerular filtration rate (eGFR) below 50 mL/min and/or plasma creatinine above 150 μmol/L.
  • Pancreatic Function: History of acute or chronic pancreatitis or amylase levels more than twice the upper limit of normal.
  • Thyroid Conditions: Previous medullary thyroid carcinoma (MTC) or a family history of MTC and/or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Cardiac Issues: Decompensated heart failure (NYHA class III or IV), unstable angina pectoris, or myocardial infarction within the past 12 months.
  • Uncontrolled Hypertension: Systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg.
  • Investigational Drugs: Receipt of any investigational drug within the past three months.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Psychiatry, Aalborg University Hospital

Aalborg, Denmark, 9000, Denmark

RECRUITING

Psychiatric Center Copenhagen, Frederiksberg Hospital

Frederiksberg, Denmark, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

AlcoholismSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Interventions

TirzepatideSodium Chloride

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, PeptideChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Anders Fink-Jensen, MD, DMSc, Professor

    Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Søren B Jensen, MD

CONTACT

+45 60294963soeren.broegger.jensen@regionh.dk

Anders Fink-Jensen, MD, DMSc

CONTACT

+45 22755843anders.fink-jensen@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, DMSc

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 22, 2025

Study Start

May 5, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

IPD will be shared upon reasonable relevant requests, e.g. for meta-analyses or independent validations. IPD will be shared anonymized or de-identified to protect participants' privacy and in accordance with relevant regulations (GDPR).

Shared Documents
STUDY PROTOCOL, SAP

Locations

DK(2)