Alcohol Use DisorderPhase 2DUALPSYCHIATRYNCT06939088
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder and Alcohol Abuse/Dependence, run by Anders Fink-Jensen, MD, DMSci at 2 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 May 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- Severe Neurological Conditions: Presence of severe neurological diseases, including severe traumatic brain injury.
- Diabetes: Type 1 or 2 diabetes
- Pregnant or Potentially Pregnant Women: WOCBP who are pregnant, breastfeeding, intend to become pregnant within the next 6 months (including 16 weeks of treatment plus two months after discontinuation of semaglutide), or are not using a highly effective contraceptive method throughout the study period. Highly effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level greater than 3 U/L at inclusion will also be excluded.
- 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.
- Alcohol Use Disorder Medication: Use of medications for alcohol use disorder (e.g., disulfiram, naltrexone, acamprosate, nalmefene) within the 28 days prior to inclusion as recorded in the Timeline Followback (TLFB) schedule.
- Investigational Drugs: Receipt of any investigational drug within the past three months.
- Weight-Lowering Medications: Use of other weight-lowering pharmacotherapy in the past three months.
- Allergic Reactions: Hypersensitivity to the active substance or any of the excipients.
- Language Barriers: Inability to speak and/or understand Danish.
- Other Conditions: Any other condition that, in the investigator\'s opinion, may interfere with participation in the trial.
- For the subgroup of participants undergoing brain scans:
- MRI Contraindications: any contraindications for MRI (e.g., magnetic implants, pacemaker, claustrophobia).
- Benzodiazepine Use: Intermittent use of benzodiazepines within 12 days prior to the scanning session is not allowed. However, regular use of a stable dose of benzodiazepines is permitted.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Psychiatry, Aalborg University Hospital
Aalborg, Denmark, 9000
René E Nielsen, Chief Physician, Professor, +45 28 72 29 62, ren@rn.dk
- Recruiting
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, Denmark, 2100
Søren B Jensen, MD, ph.d.-student, +45 60294963, soeren.broegger.jensen@regionh.dk
Anders Fink-Jensen, MD, DMSc, +45 22755843, anders.fink-jensen@regionh.dk
About this study
Official title: Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
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.
Read the detailed description
The study is a randomised (1:1), double-blinded, placebo-controlled clinical trial including 26 weeks of treatment investigating whether tirzepatide vs placebo can reduce the number of heavy drinking days in patients with comorbid diagnoses of schizophrenia and AUD. The primary endpoint will be evaluated after 16 weeks of treatment. The study will conclude after a post-intervention follow-up 14 weeks after last treatment at week 40 of the study.
108 participants will be included. 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. Eligible patients (n=50) will have an fMRI brain scan performed at baseline and in week 16. Blood tests for safety measures and secondary endpoint-measures will be performed at weeks 0, 16, 26, and 40.
- Conditions
- Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features
- Being tested
- Tirzepatide, Placebo
- Keywords
- GLP-1, Glucagon-like peptide 1, fMRI, GIP, Glucose-dependent Insulinotropic Polypeptide, Tirzepatide, Mounjaro(R), schizophrenia, alcohol, alcohol use disorder, dual diagnosis
- Medical subject headings
- Alcoholism, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro
Once weekly injections s.c. with tirzepatide (Mounjaro(R))
PlaceboDrug
Also called BD Posiflush (saline)
Once weekly injections s.c. with placebo (BD Posiflush)
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Tirzepatide once-weekly s.c.titrated to a maximum dose of 15 mg Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Saline s.c. once-weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 16 weeks of treatment
Secondary outcomes (28)
Heavy drinking days
Change in heavy drinking days measured using the TLFB method.
Measured: From baseline to 26 weeks of treatment and 14 weeks post-intervention
Total alcohol consumption
Change in total alcohol consumption measured using the TLFB method.
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Days without alcohol consumption
Change in number of days without alcohol measured using the TLFB method.
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
World Health Organization (WHO) Risk Levels of Alcohol Consumption
Change in WHO alcohol risk level measured using the TLFB method.
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Penn Alcohol Craving Scale (PACS) score
Change in Penn Alcohol Craving Scale (PACS) score. Minimum score = 0, maximum score =30. A high score means a worse outcome.
Measured: From baseline to 16 and 26 weeks of treatment
Alcohol Use Disorder Identification Test (AUDIT) score
Change in AUDIT score. Minimum score = 0, maximum score =40. A high score means a worse outcome.
Measured: From baseline to 16 and 26 weeks of treatment
Drug Use Disorders Identification Test (DUDIT) score
Change in DUDIT score. Minimum score = 0, maximum score =44. A high score means a worse outcome.
Measured: From baseline to 16 and 26 weeks of treatment
Drug use frequency
Change in drug use frequency measured using the drug use frequency section of the DUDIT-extended
Measured: From baseline to 16 and 26 weeks of treatment
Preferred substance of use
Change in preferred substance of use
Measured: From baseline to 16 and 26 weeks of treatment
Biomarkers of cannabis exposure
Changes in biomarkers of recent cannabis exposure (blood 11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC) and 11-nor-9-carboxy-delta 9-tetrahydrocannabinol (THCCOOH) levels)
Measured: From baseline to 16 and 26 weeks of treatment
The Patient Health Questionnaire (PHQ-9)
Changes in PHQ-9
Measured: From baseline to 16 and 26 weeks of treatment
Fagerströms Test for Nicotine Dependence score
Changes in smoking habits using the Fagerströms Test for Nicotine Dependence score
Measured: From baseline to 16 and 26 weeks of treatment
Number of cigarettes smoked per day
Changes in average number of cigarettes smoked per day
Measured: From baseline to 16 and 26 weeks of treatment
Cotinine levels
Change in blood cotinine levels
Measured: From baseline to 16 and 26 weeks of treatment
Blood parameters
Changes in blood parameters (GGT, ALAT, MCV)
Measured: From baseline to 16 and 26 weeks of treatment
Liver fibrosis (FIB-4 score)
Changes in FIB-4 score
Measured: From baseline to 26 weeks of treatment
Blood phosphatidyl ethanol (PEth) levels
Changes in PEth levels
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Glycaemic control parameters
Changes in HbA1c levels
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Blood pressure
Change in blood pressure
Measured: From baseline to 16 and 26 weeks of treatment
Body weight
Change in body weight
Measured: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Waist circumference
Change in waist circumference
Measured: From baseline to 16 and 26 weeks of treatment
fMRI alcohol cue-reactivity
Changes in fMRI BOLD signals in response to alcohol cues in brain regions related to reward in a subgroup (n=50) of participants
Measured: From baseline to 16 weeks of treatment
WHO-5 Subjective Well-Being Index
Changes in quality of life measured using the World Health Organization-Five Well-Being Index (WHO-5)
Measured: From baseline to 26 weeks of treatment
Global Assessment of Psychosocial Disability (GAPD)
Changes in GAPD score
Measured: From baseline to 26 weeks of treatment
Positive and Negative Syndrome Scale (PANSS-6)
Changes in symptom severity of schizophrenia measured using PANSS-6
Measured: From baseline to 26 weeks of treatment
Clinical Global Impression Severity Scale (CGI-S)
Changes in CGI-S score
Measured: From baseline to 26 weeks of treatment
Proteomics
Change in proteomics
Measured: From baseline to 16 and 26 weeks of treatment
Qualitative experience
For a subgroup of participants (n=20), qualitative interviews will be performed after 16 weeks of treatment to evaluate qualitative differences in trial participation experiences between the intervention and placebo groups, which will be assessed as a secondary outcome.
Measured: From baseline to 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start5 May 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
- Investigators
- Anders Fink-Jensen, MD, DMSc, Professor, Principal investigator, Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939088
- Sponsor's protocol ID
- The DUALPSYCHIATRY study
- Other IDs
- U1111-1312-8134, 2024-518608-28-00
- Acronym
- DUALPSYCHIATRY
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06939088
- Acronym / sponsor ID
- DUALPSYCHIATRY / The DUALPSYCHIATRY study
- Conditions
- Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features
- Keywords
- GLP-1, Glucagon-like peptide 1, fMRI, GIP, Glucose-dependent Insulinotropic Polypeptide, Tirzepatide, Mounjaro(R), schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomised (1:1), double-blinded, placebo-controlled clinical trial including 26 weeks of treatment investigating whether tirzepatide vs placebo can reduce the number of heavy drinking days in patients with comorbid diagnoses of schizophrenia and AUD. The primary endpoint will be evaluated after 16 weeks of treatment. The study will conclude after a post-intervention follow-up 14 weeks after last treatment at week 40 of the study.
108 participants will be included. 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. Eligible patients (n=50) will have an fMRI brain scan performed at baseline and in week 16. Blood tests for safety measures and secondary endpoint-measures will be performed at weeks 0, 16, 26, and 40.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideTirzepatide once-weekly s.c.titrated to a maximum dose of 15 mg |
| Placebo | Placebo comparator | Drug: PlaceboSaline s.c. once-weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed Consent: The patient must provide both oral and written informed consent.
- Diagnosis:
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: MounjaroOnce weekly injections s.c. with tirzepatide (Mounjaro(R)) | Drug | Tirzepatide |
| PlaceboAlso: BD Posiflush (saline)Once weekly injections s.c. with placebo (BD Posiflush) | Drug | Placebo |
Primary outcome
Change in heavy drinking days
Time frame: From baseline to 16 weeks of treatment
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.
28 secondary outcomes
Heavy drinking days
Time frame: From baseline to 26 weeks of treatment and 14 weeks post-intervention
Total alcohol consumption
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Days without alcohol consumption
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
World Health Organization (WHO) Risk Levels of Alcohol Consumption
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Penn Alcohol Craving Scale (PACS) score
Time frame: From baseline to 16 and 26 weeks of treatment
Alcohol Use Disorder Identification Test (AUDIT) score
Time frame: From baseline to 16 and 26 weeks of treatment
Drug Use Disorders Identification Test (DUDIT) score
Time frame: From baseline to 16 and 26 weeks of treatment
Drug use frequency
Time frame: From baseline to 16 and 26 weeks of treatment
Preferred substance of use
Time frame: From baseline to 16 and 26 weeks of treatment
Biomarkers of cannabis exposure
Time frame: From baseline to 16 and 26 weeks of treatment
The Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to 16 and 26 weeks of treatment
Fagerströms Test for Nicotine Dependence score
Time frame: From baseline to 16 and 26 weeks of treatment
Number of cigarettes smoked per day
Time frame: From baseline to 16 and 26 weeks of treatment
Cotinine levels
Time frame: From baseline to 16 and 26 weeks of treatment
Blood parameters
Time frame: From baseline to 16 and 26 weeks of treatment
Liver fibrosis (FIB-4 score)
Time frame: From baseline to 26 weeks of treatment
Blood phosphatidyl ethanol (PEth) levels
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Glycaemic control parameters
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Blood pressure
Time frame: From baseline to 16 and 26 weeks of treatment
Body weight
Time frame: From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention
Waist circumference
Time frame: From baseline to 16 and 26 weeks of treatment
fMRI alcohol cue-reactivity
Time frame: From baseline to 16 weeks of treatment
WHO-5 Subjective Well-Being Index
Time frame: From baseline to 26 weeks of treatment
Global Assessment of Psychosocial Disability (GAPD)
Time frame: From baseline to 26 weeks of treatment
Positive and Negative Syndrome Scale (PANSS-6)
Time frame: From baseline to 26 weeks of treatment
Clinical Global Impression Severity Scale (CGI-S)
Time frame: From baseline to 26 weeks of treatment
Proteomics
Time frame: From baseline to 16 and 26 weeks of treatment
Qualitative experience
Time frame: From baseline to 16 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Fink-Jensen, MD, DMSc, Professor principal investigator
Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder and Alcohol Abuse/Dependence, run by Anders Fink-Jensen, MD, DMSci at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Søren B Jensen, MD (+45 60294963, soeren.broegger.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heavy drinking days (time frame: From baseline to 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.