Tirzepatide for Alcohol Use Disorder

NCT06994338 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HS-25-002731R21AA031892-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.

Conditions

Alcohol Use Disorder; Obesity and Overweight; Alcohol

Keywords

Tirzepatide; GLP-1; Addiction; Alcohol

Outcome Measures

Primary Outcomes (1)

• Number of heavy drinking days

  Number of heavy drinking days (NHDD) during the last four weeks of treatment (treatment Weeks 5-8), as measured by the Timeline Followback interview. NHDD is defined as the total number of days on which participants consumed 5 or more drinks (for men) or 4 or more drinks (for women). The analysis of NHDD will control for baseline NHDD (defined as NHDD in the four weeks preceding treatment).

  Last 4 weeks of treatment (Weeks 5-8)

Secondary Outcomes (5)

• Drinks per drinking day

  Last 4 weeks of treatment (Weeks 5-8)

• WHO drinking risk level

  Last 4 weeks of treatment (Weeks 5-8)

• Abstinent days

  Last 4 weeks of treatment (Weeks 5-8)

• Absence of heavy drinking

  Last 4 weeks of treatment (Weeks 5-8)

• Alcohol craving

  Last 4 weeks of treatment (Weeks 5-8)

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Drug: Placebo injections

Interventions

Tirzepatide DRUG

Tirzepatide injections (2.5mg, 5.0mg)

Tirzepatide

Placebo injections DRUG

Placebo injections

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
• Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
• Body mass index ≥ 27kg/m2
• Willingness to attend weekly medication visits and complete all study procedures
• Ability to read and communicate in English
• Age 21-65
• Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
• Stable housing status

You may not qualify if:

• Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
• Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.
• History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related symptoms; a CIWA score \>9 at assessment; or a baseline score 4+ on the Prediction of Alcohol Withdrawal Severity (PAWS) scale.
• Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
• History of chronic or acute pancreatitis
• History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%
• History of suicide attempt or report of current (past 2 weeks) active suicidal ideation
• Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)
• Treatment for eating disorder in the past 12 months
• Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians
• History of known liver disease
• Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\>3x upper limit of normal range)
• History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer
• Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
• Weight loss \> 5% in the 30 days prior to screening

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Keck School of Medicine, University of Southern California

Los Angeles, California, 90032, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Obesity; Overweight; Behavior, Addictive

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Christian Hendershot, Ph.D.

CONTACT

(323) 442-1082; christian.hendershot@usc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Clinical Research

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 29, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)