Not yet recruitingPhase 2

Combination Therapy for Alcohol Use Disorder

Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder

Lead sponsor

Johns Hopkins University

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Alcohol / substance use

Eligibility highlights

Primary endpoint

•Treatment-emergent AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07249554

Org study IDIRB00531545

Timeline

Milestones

Study first posted2025-11-25actual

Last update posted2026-05-12actual

Study start2026-07estimated (month precision)

Primary completion2028-07estimated (month precision)

Study completion2028-09estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Aged 21-65 years old

•Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.

•Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder

•Willing to comply with the study protocol

Exclusion criteria

•Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization

•Currently pregnant, breastfeeding

•Unwilling to use contraceptives (e.g., condoms and/or hormonal birth control)

•Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder

•History of pancreatitis

•History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.

•Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy

•Levels of amylase, lipase, aspartate aminotransferase (AST), and/or alanine transferase (ALT) greater than 2x upper limit of normal

•Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide

•Diagnosis of cancer within past 5 years

•History of multiple endocrine neoplasia syndrome type 2 (MEN2)

•Currently taking any medications contraindicated with GLP-1 agonists and/or naltrexone.

•BMI <18.5

•Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)

•Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.

•Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).

•Allergies to semaglutide and/or naltrexone

•Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen

•Prescribed or taking the following medications in the past four weeks:

•The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).

•The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.

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.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Participant-reported Adverse Events

Time frame:14 days

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 6, 2026 snapshot.