NCT07292519

Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)

Not yet recruiting Phase 2 Last updated 18 December 2025

What this trial tests

Phase 2 trial testing Tirzepatide in Alcohol Use Disorder (AUD) in 46 participants. Not yet recruiting.

Timeline

15 January 2026

Primary endpoint
15 May 2027

15 January 2028

Quick facts

Lead sponsor	South West Sydney Local Health District
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	15 January 2026
Primary completion	15 May 2027
Estimated completion	15 January 2028
Sites	1 location across Australia

Drugs / interventions tested

• Tirzepatide (TIRZEPATIDE) — full drug profile →
• Take Control CBT Module
• Placebo

Conditions studied

• Alcohol Use Disorder (AUD) — all drugs for Alcohol Use Disorder (AUD) →
• Overweight or Obese — all drugs for Overweight or Obese →
• Comorbidities and Coexisting Conditions — all drugs for Comorbidities and Coexisting Conditions →

Sponsor

South West Sydney Local Health District — full company profile →

Who can join

Adults 21 to 75, any sex, with Alcohol Use Disorder (AUD) or Overweight or Obese. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight/obesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. GLP-1 Receptor Agonists for Treating Alcohol Use Disorder: A Critical Review.
   Woo S, Zhu G, Castro C, Phuong A, et al · · 2026 · PMID 42144979 · DOI 10.1111/acer.70312
2. Incretin-Based Therapies: A Novel Pathway in Addiction Treatment
   Dawid R, Joanna M, Justyna M, Bogdańska A, et al · · 2026