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Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
46
estimated
Study population
Alcohol / substance use, Obesity / overweight
Key I/E criterion
•BMI ≥27
Primary endpoint
•Alcohol consumption, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Aged 21 to 75 years
2. Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year)
3. Have an average daily alcohol consumption of:
4. Body mass index (BMI) ≥27 kg/m²
5. Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment
6. Able and willing to attend weekly clinic visits and complete all study procedures
7. Fluent in English and able to provide informed consent
8. Stable housing situation (not transient or homeless)
Exclusion criteria
1. Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder)
2. Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances
3. History of significant alcohol withdrawal, defined by:
4. Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months
5. History or current diagnosis of:
6. Significant psychiatric illness, including:
7. Chronic or acute pancreatitis
8. Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin >3× ULN)
9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I/II
10. Estimated glomerular filtration rate (eGFR) <30 mL/min
11. Recent significant weight loss (>5% of body weight in past 30 days)
12. Use of any weight loss medication (e.g., orlistat, bupropion-naltrexone) or AUD medication (e.g., naltrexone, acamprosate, topiramate, varenicline) in the past 3 months
13. Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months
14. Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential)
15. Inability to attend weekly visits due to work/travel/schedule conflicts
16. Participation in another clinical trial involving an investigational product
17. Shared household with a current or past participant in this trial
18. Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up
19. History of muscle wasting, bone disorders (e.g. sarcopenia)
20. Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD)
21. Uncontrolled hypertension, recent heart attack or stroke (within 6 months)
Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging \& Psychophysiology Tasks:
22. Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants
23. History of brain surgery or penetrating head trauma
24. Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments)
25. Non-removable piercings or dental hardware that would interfere with MRI
26. History of claustrophobia likely to interfere with scanning compliance aa. Neurological disorders (e.g., epilepsy, multiple sclerosis) likely to confound neuroimaging data bb. Inability to lie still or tolerate MRI procedures cc. Patient weighting over 159kg (MRI scan limit) dd. Any other condition or medication judged by the investigator to preclude safe participation
Endpoints (47)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsBody weight
Time frame:Measured at baseline [week 0] and at end of treatment [week 9].
Body weight, absolute change (kg)
change from baseline, improvement
Waist circumference
Time frame:Measured at baseline [week 0] and at end of treatment [week 9]
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
1 endpointHbA1c
Time frame:3 weeks (Measured at baseline [week 0] and at end of treatment [week 9], and week 12 if clinically indicated)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
4 endpointsBlood pressure
Time frame:9 weeks (weekly, from baseline visit to final dose at week 8)
change from baseline, improvement
10-year ASCVD risk score
Time frame:Measured at baseline [week 0] and end of treatment [week 9].
change from baseline, improvement
Total cholesterol
Time frame:3 weeks (Measured at baseline [week 0] and at end of treatment [week 9], and week 12 if clinically indicated)
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Triglycerides
Time frame:3 weeks (Measured at baseline [week 0] and at end of treatment [week 9], and week 12 if clinically indicated)
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Patient-reported / QoL
18 endpointsChanges in Positive and Negative Mood States
Time frame:Week 1 (prior to dose 1) and at EOT (end of treatment/week 8)
change from baseline, improvement
Changes in depressive symptom severity
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
change from baseline, improvement
Change in sleep disturbance and sleep problems
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
change from baseline, improvement
Change in health-related quality of life
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
SF-36 total
change from baseline, improvement
Evaluation of treatment acceptability
Time frame:Week 9 and optional Week 12
descriptive
Alcohol urge
Time frame:Week 0 and Week 9 (before and after the Psychophysiological cue-reactivity tasks [if agreed to by the participant])
descriptive, improvement
Changes in anxiety symptom severity
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
change from baseline, improvement
Depression severity
Time frame:Measured weekly from baseline (week 1) to outcomes/discharge (week 12)
change from baseline, improvement
Changes in withdrawal status (#2)
Time frame:Measured weekly from baseline (week 1) to final follow up visit (week 12)
change from baseline, improvement
Impulsive traits
Time frame:Measured at baseline
descriptive
Measure of positive reinforcement from the environment
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
change from baseline, improvement
Reward driven eating tendencies
Time frame:Measured weekly from baseline (week 1) to final follow up visit (week 12)
change from baseline, improvement
Trait level food craving tendencies
Time frame:Measured at baseline and at follow-up 1 (safety outcomes, week 9)
change from baseline, improvement
Anhedonia (ability to experience pleasure in last few days)
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
descriptive, improvement
Self-efficacy for maintaining abstinence
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
change from baseline, improvement
Compulsions and obsessive thoughts related to alcohol use
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
change from baseline, improvement
Food cravings at a specific point in time
Time frame:Measured weekly from baseline (week 1) to final follow up visit (week 12)
change from baseline, improvement
Intensity of cigarette craving
Time frame:Measured weekly from baseline (week 1) to final follow up visit (week 12)
change from baseline, improvement
Safety / tolerability / PK
3 endpointsFrequency and severity of side effects/adverse events (AEs)
Time frame:12 weeks (at each visit)
Treatment-emergent AEs (any)
descriptive
Number of treatment-related discontinuation
Time frame:12 weeks (at each visit)
Discontinuation due to AE
event count, event
Changes in suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).
Time frame:12 weeks (measured weekly)
change from baseline, event
Other clinical outcomes
19 endpointsHeavy Drinking Days
Time frame:12 weeks (measured at baseline, during the final 4 weeks of treatment [weeks 5 - 8], end of treatment [week 9], and follow-up [week 12]).
Alcohol consumption, change
change from baseline, improvement
Number of drinks per drinking day consumed
Time frame:12 weeks (weekly, from baseline visit to final follow-up visit at week 12)
Alcohol consumption, change
change from baseline, improvement
Abstinent days
Time frame:12 weeks (weekly, from baseline visit to final follow-up visit at week 12)
descriptive, improvement
Alcohol Craving
Time frame:12 weeks (weekly, from baseline visit to final follow-up visit at week 12)
change from baseline, improvement
WHO drinking risk level scale.
Time frame:12 weeks (weekly, from baseline visit to final follow-up visit at week 12)
categorical status, improvement
Proportion of participants with zero heavy drinking days
Time frame:4 weeks (weeks 5 to 8)
threshold achievement, improvement
Alcohol craving measure 2
Time frame:12 weeks - measured weekly from baseline (week 1) to outcomes/discharge (week 12)
Alcohol consumption, change
change from baseline, improvement
Changes in cigarette use
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
change from baseline, improvement
Changes in cannabis use
Time frame:At baseline (week 0) and at end-of-treatment visit (week 9).
Alcohol consumption, change
change from baseline, improvement
Changes in phosphatidylethanol (PEth), an objective biomarker of alcohol use
Time frame:Baseline (Week 0), End-of-treatment (week 9) and optionally at week 12
change from baseline, improvement
Daily fluctuations in alcohol use, craving, and mood
Time frame:Daily throughout the 12 weeks using the SEMA application
Alcohol consumption, change
descriptive
componentsAlcohol consumption, change, PGI, change
Withdrawal Status
Time frame:Prior to neuroimaging at baseline [week 0] and the final imaging date [between week 7 and 9].
change from baseline, improvement
To determine risk of severe alcohol withdrawal
Time frame:Measured at screening (first visit) to determine withdrawal severity status
descriptive
Alcohol use severity
Time frame:Measured at baseline
AUDIT score
descriptive
Nicotine dependence
Time frame:Measured at baseline
descriptive
Difficulty controlling alcohol consumption
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
AUDIT score
descriptive, improvement
Drinking frequency in high-risk situations
Time frame:Measured at baseline (week 1), dosing visit 5 (mid-point of medication schedule) and at the first (safety outcome, week 9) and second follow-up visits (outcomes/discharge, week 12)
Alcohol consumption, change
change from baseline, improvement
Presence and severity of food addiction symptoms
Time frame:Measured at baseline
descriptive
Motivation and demand for alcohol.
Time frame:Measured weekly from baseline (week 1) to final follow up visit (week 12)
descriptive, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.