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
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 minutesCmax 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 minutesTmax 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 minutesData 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 minutesData derived from breath alcohol test.
Ethanol Elimination Rate: Urine samplesprior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutesData derived from urine samples.