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TerminatedPhase 1Results posted

The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

8

actual

Study population

Alcohol / substance use

Key I/E criterion

Primary endpoint

Alcohol consumption, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03645408
Org study IDH-38015
Secondary IDR21AA027332-01

Timeline

Milestones

Study first posted2018-08-24actual
Study start2019-05-02actual
Primary completion2021-07-01actual
Study completion2021-07-01actual
Last update posted2022-02-09actual
Results first posted2022-02-09actual

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age21 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Alcohol Consumption

Time frame:2 hours

Alcohol consumption, change

descriptive, improvement

Posted result

GroupValue (mean), standard drink units (SDUs)95% CI
Exenatide Injection0.93
Sham Injection (Placebo)2.78

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.