42 Participants Needed

Tirzepatide for Alcoholism

CH
Overseen ByChristian Hendershot, Ph.D.
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults who struggle with alcohol use disorder and are also overweight or obese. Participants should be seeking treatment for their alcohol consumption.

Inclusion Criteria

Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
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Exclusion Criteria

Currently enrolled in another clinical trial involving an investigational product
Treatment for eating disorder in the past 12 months
Current contact or co-habitation with a current or former participant in the present trial
See 28 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly tirzepatide or placebo to evaluate effects on alcohol consumption and cardiometabolic outcomes

8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Tirzepatide
Trial Overview The study tests the effects of tirzepatide, a weekly injection, against a placebo to see if it helps reduce alcohol intake and improve heart-related health measures in participants.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
2.5mg (Weeks 1-4), 5.0mg (Weeks 5-8)
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+
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