A Phase 2 interventional study of Placebo and Glucagon-Like Peptide-1 Agonist (GLP-1) in Alcohol Use Disorder, sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.
Approximately 29 million persons in the United States aged 12 and older experienced a form of Alcohol Use Disorder (AUD) in 2023. Currently, only three pharmacotherapies are FDA-approved to treat AUD: acamprosate, naltrexone, and disulfiram. As monotherapies, these have shown moderate efficacy in reducing alcohol consumption and increasing abstinence. There is some evidence that therapeutic effects can be enhanced when combined with other medications. Recently, emerging preclinical evidence suggests that endogenous GLP-1 signaling plays a role in alcohol-mediated behaviors. Further, growing clinical data suggest that GLP-1 agonists (e.g., Wegovy, Rybelsus, Mounjaro) may be effective for the treatment of AUD. Studies evaluating the efficacy of GLP-1 agonists in combination with FDA-approved medications for AUD have yet to be conducted. The investigators hypothesize that combining a GLP-1 agonist and naltrexone may be more effective for reducing dimensions of AUD than naltrexone alone. The goal of this study is to collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for AUD. Following one week of in-patient enrollment, participants will be randomized to one of three conditions in a double dummy design: placebo + placebo, GLP-1 + placebo, or GLP-1 + naltrexone. All study medications will be administered orally. Participants randomized to active GLP-1 conditions will receive 3 mg during study week 1 and can increase to 7 mg during week 2. Participants will attend study visits in a 14-day period to complete assessments of alcohol craving, alcohol demand, anhedonia, eating behaviors, and subjective effects. Participants will also provide vitals and biosamples to evaluate health outcomes.
Exclusion Criteria:
Placebo+Placebo
Drug: Placebo
Placebo+GLP-1
Drug: Placebo · Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)
GLP-1+Naltrexone
Drug: Glucagon-Like Peptide-1 Agonist (GLP-1) · Drug: Naltrexone (oral tablets)
Over-encapsulated non-active microcrystalline cellulose
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
Over-encapsulated Naltrexone (oral tablets)
Participant-reported Adverse Events
Participant-reported adverse events during the course of the trial
Time frame: 14 days
Plan to share: No — Data may be shared upon request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University