NCT03645408 trial results

Inclusion Criteria: 1. 21-55 years of age. 2. Able to verify age with a state or federal picture identification. 3. Exceeds safe weekly drinking limits \[4 standard drink units (SDUs) for women or 21 SDUs for men per week\] 4. Reports at least one episode of binge drinking (\>3 SDUs for women, \>4 SDUs for men) an average of once per week in the four weeks prior to baseline screening. 5. Meets Diagnostic And Statistical Manual Of Mental Disorders, Fifth Edition (DSM-5)criteria for mild alcohol use disorder or greater severity. Exclusion Criteria: 1. Seeking treatment for alcohol problems. 2. Clinical Institute Withdrawal Assessment at ≥10 3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine, marijuana or caffeine. 4. If female, pregnant, nursing, have plans to become pregnant. 5. If female, does not agree to use an accepted form of birth control. 6. Has a medical contraindication to the use of exenatide. 7. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated. 8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS). 9. BMI is less than 18 or greater than or equal to 30. 10. History of diabetes. 11. Baseline hemoglobin A1c ≥ 6.5% 12. Baseline non fasting glucose \>200 13. Significantly elevated serum lipase levels. 14. Impaired renal function (GFR \<80 mL/min). 15. Pancreatitis, gastroparesis or other severe gastrointestinal disease. 16. Has had gastric bypass surgery 17. Subject is currently taking warfarin. 18. Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days. 19. Has taken medications that are used to treat alcohol use disorder (AUD) in the past 90 days. 20. Subjects with a history of thyroid cancer or other thyroid disease. 21. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines. 22. Prior history of anaphylaxis or angioedema with another GLP-1 receptor agonist. 23. Prior use of exenatide 24. Liver function values AST or ALT are twice the normal limit 25. Unable to comfortably abstain from nicotine for a period of 8 hours. 26. Has Chronic obstructive pulmonary disease (COPD), history of solid organ transplant, sickle cell disease, severe heart disease or other health condition for which exposure to COVID-19 represents an unreasonable risk as determined by the study staff physician using accepted COVID-19 guidance (e.g. Centers for Disease Control, etc.). 27. Subject has prior history of Drug-induced thrombocytopenia