Clinical trial

Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics

Opening soon · Phase 1 · 1 countries · Registry ID NCT07758231

Opening soonPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionGLP-1, Alcohol

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

Acute Ethanol Dose

Drug

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.

Primary outcomes

Maximum Ethanol Concentration (Cmax)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

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

Time to Maximum Ethanol Concentration (Tmax)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

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

Ethanol Elimination Rate: Blood samplesprior 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

Data derived from blood samples.

Ethanol Elimination Rate: Breath testsprior to dosing (-25 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes

Data derived from breath alcohol test.

Ethanol Elimination Rate: Urine samplesprior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes

Data derived from urine samples.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Wisconsin🇺🇸 Madison, Wisconsin, United States