Tirzepatide Phase 2 trial to evaluate alcohol consumption and cardiometabolic outcomes in AUD-OOB

Individuals with Alcohol Use Disorder (AUD) often present with co-occurring overweight or obesity (OOB), a complex patient population facing heightened relapse rates and significant cardiometabolic risk. Current therapeutic strategies for AUD frequently fall short for these individuals, leaving a critical unmet need for interventions that can address both conditions simultaneously. Glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR) co-agonists, such as tirzepatide, have demonstrated robust efficacy in weight management and glycemic control. Emerging preclinical and preliminary clinical evidence also suggests these agents may reduce alcohol intake and craving, positioning tirzepatide as a promising candidate to target the intricate interplay between AUD and metabolic dysfunction. This trial aims to explore this potential dual therapeutic benefit.

This is a Phase 2 randomized controlled pilot trial actively recruiting adults diagnosed with Alcohol Use Disorder and co-occurring overweight or obesity. Participants will be randomized to receive either weekly subcutaneous injections of tirzepatide or Saline Placebo. The tirzepatide arm will follow a specific titration schedule: 2.5 mg weekly for 4 weeks, followed by 5 mg weekly for an additional 4 weeks, for a total of 8 weeks. Both groups will concurrently participate in a structured behavioral intervention called Take Control. The primary endpoint is the change in alcohol consumption, with secondary endpoints focusing on various cardiometabolic outcomes and patient-reported measures.

As a recruiting Phase 2 pilot randomized controlled trial, this study is currently in progress and has not yet reported findings. The primary aim is to rigorously examine the effects of weekly tirzepatide versus placebo, combined with a behavioral intervention, on alcohol consumption in the target population. > Specifically, researchers intend to quantify reductions in drinks per day and heavy drinking days, assessing the efficacy of tirzepatide 2.5 mg and 5 mg doses over an 8-week period. Secondary aims include evaluating changes in cardiometabolic outcomes such as body weight, glycemic parameters, lipid profiles, and blood pressure, alongside assessments of alcohol craving and quality of life. The trial seeks to establish preliminary efficacy and safety data for tirzepatide in this dual-diagnosis cohort, providing crucial insights for potential larger-scale studies and informing future clinical trial designs.