NCT07758231

Brief Summary

This study is to learn how the weight loss drug tirzepatide (Zepbound) changes the way a body handles alcohol. 5 participants aged 21-55 who take Zepbound will be enrolled and can expect to be on study for up to 4 weeks.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
5mo left

Started Oct 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

GLP-1Alcohol

Outcome Measures

Primary Outcomes (5)

  • Maximum Ethanol Concentration (Cmax)

    Cmax will be determined from visual inspection of the concentration-time plots.

    prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes

  • Time to Maximum Ethanol Concentration (Tmax)

    Tmax will be determined from visual inspection of the concentration-time plots.

    prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes

  • Ethanol Elimination Rate: Blood samples

    Data derived from blood samples.

    prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes

  • Ethanol Elimination Rate: Breath tests

    Data derived from breath alcohol test.

    prior to dosing (-25 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes

  • Ethanol Elimination Rate: Urine samples

    Data derived from urine samples.

    prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes

Secondary Outcomes (5)

  • Biphasic Alcohol Effects Scale (BAES) Score

    5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes

  • Risk Perception and Safety Appraisal (RPSA) Score

    5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes

  • Divided Attention Task (DAT)

    prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes

  • Digital Symbol Substitution Task (DSST)

    prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes

  • Paced Serial Addition Task (PSAT)

    prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes

Study Arms (1)

Healthy adults on Tirzepatide

EXPERIMENTAL

Participants will complete a screening and enrollment visit, one study visit, and a follow-up correspondence over the course of approximately 4 weeks.

Drug: Acute Ethanol Dose

Interventions

Acute Ethanol DoseDRUG

Time 0, participants will self-administer an oral ethanol beverage (vodka and sugar-free cherry Kool aid) calculated to reach a peak Breath Alcohol Concentration (BrAC) of 0.08 g/dL using the Widmark formula. A total time of 30 minutes will be given for completion of beverage consumption. This will be followed by a breakfast.

Also known as: vodka
Healthy adults on Tirzepatide

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 21 years of age, no older than 55 years of age
  • BMI 30-45 kg/m2
  • Taking stable dose of prescribed, branded tirzepatide for at least 28 days
  • Self-reported regular alcohol consumption
  • Good mental health as determined by self-reported responses to the Psychopathology Screener and review by Study Physician as necessary
  • Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener
  • In possession of a valid drivers' license with at least two years of driving experience
  • English-speaking (able to provide consent and complete questionnaires)
  • Written Informed Consent

You may not qualify if:

  • AUDIT score of \>8 requires Study Physician review
  • Use of compounded GLP-1 RA
  • History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener, Drug Use Disorders Identification Test, Alcohol Use Disorder Identification Test
  • Pregnancy or lactation (pregnancy test, if needed)
  • Use of medications that may impact cognitive ability or potentiate alcohol (e.g., mood stabilizers, sedatives)
  • Use of medications that are known to significantly delay gastric emptying as determined by Study Physician
  • History of pancreatitis, severe gastroparesis, or personal or family history of medullary thyroid or multiple endocrine neoplasia syndrome type 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Heather Barkholtz, PhD

    UW School of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Michael Chen, MD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Barkholtz, PhD

CONTACT

608-890-1967hbarkholtz@wisc.edu

Michael Chen, MD

CONTACT

michael.chen@fammed.wisc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-site, open-label, single-arm pilot study evaluating the pharmacokinetics and pharmacodynamics of ethanol in participants receiving maintenance GLP-1 RA therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 11, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Data, including transcriptions of audio-recordings of the driving simulator experiments and biological specimens, will be stored for future use. The original digital audio recordings will not be banked for future use, only the transcription documents containing only experiment-relevant words spoken by the participant will be kept. Only members of the study team will have access to the data and specimens. Prior to banking, identifiers (including linking codes) will be removed from the data and biological specimens. Since identifiers will be removed from the data and biological specimens, participants will not be able to withdraw their banked data and specimens from future research use. Data will be released only as anonymized aggregates after careful consideration and approval of one of the study PIs. No genetic testing will take place on any banked biological specimen.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)