DelfaGLP-1 Atlas

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RecruitingPhase 2

Semaglutide Therapy for Alcohol Reduction (STAR)

Semaglutide Therapy for Alcohol Reduction (STAR): A Proof-of-Concept Phase II Clinical Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

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 IDNCT06015893
Org study ID10001603
Secondary ID001603-DA

Timeline

Milestones

Study first posted2023-08-29actual
Study start2023-10-17actual
Last update posted2026-05-27actual
Primary completion2030-12-31estimated
Study completion2030-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
Maximum age110 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•INCLUSION CRITERIA:

This study will enroll adult individuals with a current diagnosis of AUD. Participants will be recruited without any preference to sex, race, religion, or other social variables, but sociodemographic data will be collected for sample characterization and potential use in the analyses. Since self-reported psychological measures that have been validated in English constitute major part of the study assessments, participants need to be able to speak, read, write, and understand English to be in the study.

The information needed to assess eligibility will be collected under an IRB-approved NIDA IRP

screening protocol, led by the Office of the Clinical Director (OCD) at the NIDA IRP to assess

potential research participants' eligibility for entering clinical protocols. Additional details can be found in the NIDA screening protocol documents. Furthermore, NIH medical records (from other NIH clinical protocols) and outside medical records may also be used, if available, to determine whether participants fulfill the eligibility criteria.

To be eligible for this study, an individual must meet all of the following criteria:

•At least 18 years old
•Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
•Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of > 7 drinks per week for females or > 14 drinks per week for males during the 28-day period prior to screening plus at least four days with > 3 drinks for females or > 4 drinks for males during the 28-day period prior to screening
•Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10
•Able to speak, read, write, and understand English as demonstrated by ability to understand and sign the NIDA screening protocol consent
•Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing

Exclusion criteria

An individual who meets any of the following criteria will be excluded from enrolling in this study:

•BMI < 23 kg/m^2 or BMI >= 50 kg/m^2
•Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
•Most recent blood tests: creatinine >= 2 mg/dL, eGFR <45 mL/min/1.73 m^2, triglycerides > 500 mg/dl, ALP > 4x the upper limit of normal, clinically abnormal lipase levels per study clinician
•Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) >= 6.5 %
•Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors
•Current or prior use of semaglutide or tirzepatide
•Current (within the past 30 days) use of weight-lowering medications
•Current (within the past 30 days) use of FDA-approved pharmacotherapy for AUD (oral or intramuscular naltrexone, acamprosate, disulfiram)
•Current (within the past 30 days) use of medications with known interaction with semaglutide
•Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
•Known ongoing history of alcohol ketoacidosis, gastroparesis, pancreatitis (either acute or chronic), pancreatic carcinoma, gallbladder disease, jaundice, Mallory-Weiss syndrome (esophageal tears secondary to vomiting), esophageal varices, cirrhosis
•Known history of gastric bypass surgery
•Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue
•Known history of suicidal attempts (within the past 24 months) or active suicidal ideation
•Known history of clinically significant vestibular disorders or motion sickness
•Known history of clinically significant noise-induced hearing loss or tinnitus
•Contraindication(s) for brain fMRI
•Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)
•Physical and/or mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.
•Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
•Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

Endpoints (7)

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.

Coverage by outcome category

Other clinical outcomes
6
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Determine the safety and tolerability of semaglutide in individuals with AUD.

Time frame:Number and severity of adverse events; number of people who reach the target dose.

descriptive

Other clinical outcomes

6 endpoints
Primary/protocol endpoint

Determine whether semaglutide, compared to placebo, reduces alcohol drinking.

Time frame:Difference in number of standard alcohol-containing drinks consumed / week (Drinks Per Week, DPW) from baseline to end of the study.

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Determine whether semaglutide reduces brain activity in resting-state and/or task-based fMRI scans.

Time frame:Difference in relevant fMRI measures between the two groups.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Determine whether semaglutide reduces and/or changes food choices in a virtual reality buffet-like laboratory.

Time frame:Difference in food selection in the virtual buffet between the two groups.

descriptive, improvement

Secondary/protocol endpoint

Determine whether semaglutide reduces alcohol/food cue-elicited craving assessed in a bar-like laboratory.

Time frame:Difference in alcohol/food craving scores post exposure between the two groups.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Determine whether semaglutide reduces blood Phosphatidylethanol (PEth) levels as a biomarker of alcohol use.

Time frame:Difference in blood PEth levels from baseline to end of the study.

change from baseline, improvement

Secondary/protocol endpoint

Determine whether semaglutide, compared to placebo, reduces other self-reported alcohol-related outcomes.

Time frame:Difference in other alcohol-related outcomes (e.g., heavy drinking days, drinks per drinking days, WHO drinking levels) from baseline to end of the study.

Alcohol consumption, change

change from baseline, improvement

Publications (9)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.