GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05520775

CompletedPhase 2Results posted

Semaglutide for Alcohol Use Disorder

Human Laboratory Screening of Semaglutide for Alcohol Use Disorder

Lead sponsor

University of North Carolina, Chapel Hill

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoints

•Alcohol consumption, change•Breath Alcohol Concentration

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 IDNCT05520775

Org study ID21-1689

Secondary IDR21AA026931-02

Timeline

Milestones

Study first posted2022-08-30actual

Study start2022-09-02actual

Primary completion2024-04-12actual

Study completion2024-04-19actual

Results first posted2025-03-24actual

Last update posted2025-04-02actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age 21-65

•Meeting DSM-5 criteria for current (past year) alcohol use disorder (with 2-7 symptoms endorsed) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for current at-risk drinking (i.e., >7/14 drinks in one week for women/men, with at least two episodes of 4+/5+ drinks in the past 30 days)

•Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring

•Willingness to complete laboratory sessions involving alcohol administration

•Ability to communicate and read in English

Exclusion criteria

•Reporting past 30-day use of illicit drugs other than cannabis at baseline, or having a positive toxicology screen for illicit drugs other than cannabis at baseline

•Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)

•Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use

•Past 30-day use of: Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide;, or weight control medications

•Prior use of semaglutide or other GLP-1 agonists

•Known or suspected hypersensitivity to study medication or related products

•Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)

•History of suicide attempt, or recent (past 30 day) suicidal ideation, or psychiatric hospitalization in the last 6 months

•Current significant medical or neurological illness (based on self-report or medical record) including severe hepatic impairment or cirrhosis, impaired renal function (eGFR <50ml/min), acute or chronic pancreatitis, gastroparesis, gallbladder disease or cholelithiasis, other severe gastrointestinal disease, heart failure, coronary artery disease, stroke, seizure disorder, or other medical condition that poses a risk for the medication or alcohol administration components of the study (as determined by the MD)

•A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B

•Calcitonin greater than or equal to 50 ng/L

•Uncontrolled thyroid disease at screening

•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

•History of Type 1 or Type 2 diabetes, or HbA1c >6.5% measured at screening

•History of diabetic retinopathy, proliferative retinopathy, or maculopathy

•History of diabetic ketoacidosis

•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

•Currently nursing, pregnant, anticipating pregnancy in the next 6 months, or not using a highly effective contraceptive method as judged by the MD, and defined as:

1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)

2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)

3. intrauterine device

4. intrauterine hormone-releasing system

5. bilateral tubal occlusion

6. vasectomized partner

7. sexual abstinence

•Elevation of serum lipase, amylase, direct (conjugated) bilirubin, or alkaline phosphatase (ALP), ALT, or AST) more than 3X the upper limit of normal on baseline bloodwork

•Baseline body mass index (BMI) <23kg/m^2

•Uncontrolled hypertension or systolic BP >180 mmHg and/or diastolic BP >105 mmHg, averaged from three measurements

•Plans for travel outside of the local area in the upcoming 12 weeks that would interfere with lab visits during the study period (or other logistic factors that would make it difficult to commit to entire duration of study)

Endpoints (22)

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

Patient-reported / QoL

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Other/protocol endpoint

Change in Weight

Time frame:baseline (Week 0) to study endpoint (Week 10)

Body weight, absolute change (kg)

change from baseline, improvement

Other_pre_specified/registry result

Change in Weight

Time frame:baseline (Week 0) to study endpoint (Week 10)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Other/protocol endpoint

Change in HbA1c

Time frame:baseline (Week 0) to study endpoint (Week 10)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other_pre_specified/registry result

Change in HbA1c

Time frame:baseline (Week 0) to study endpoint (Week 10)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

Time frame:Baseline (Week 0) to post-treatment (Week 8)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide	.45	—
Sham/Placebo	-1.28	—

Secondary/registry result

Change in Subjective Sedation (Biphasic Alcohol Effects Scale)

Time frame:baseline (Week 0) to post-medication (Week 8)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide	0.14	—
Sham/Placebo	-3.22	—

Secondary/protocol endpoint

Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

Time frame:Baseline (Week 0) to post-treatment (Week 8)

change from baseline, improvement

Secondary/protocol endpoint

Change in Subjective Sedation (Biphasic Alcohol Effects Scale)

Time frame:baseline (Week 0) to post-medication (Week 8)

change from baseline, improvement

Other clinical outcomes

14 endpoints

Primary/registry result

Change in Alcohol Consumed

Time frame:Baseline (Week 0) to post-medication (Week 8)

Alcohol consumption, change

change from baseline, improvement

Posted result

Group	Value (mean), grams	95% CI
Semaglutide	-32.72	—
Sham/Placebo	-6.95	—

Primary/registry result

Change in Breath Alcohol Concentration

Time frame:Baseline (Week 0) to post-medication (Week 8)

Alcohol consumption, change

change from baseline, improvement

Posted result

Group	Value (mean), g/dl	95% CI
Semaglutide	-0.034	—
Sham/Placebo	-0.016	—

Primary/protocol endpoint

Change in Alcohol Consumed

Time frame:Baseline (Week 0) to post-medication (Week 8)

Alcohol consumption, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Breath Alcohol Concentration

Time frame:Baseline (Week 0) to post-medication (Week 8)

change from baseline, improvement

Secondary/registry result

Change in Alcohol Demand (Alcohol Purchase Task)

Time frame:Baseline (Week 0) to post-treatment (Week 8)

Alcohol consumption, change

change from baseline, improvement

Posted result

Group	Value (mean), number of drinks	95% CI
Semaglutide	-2.91	—
Sham/Placebo	-2.90	—

Secondary/registry result

Change in Cigarette Demand (Cigarette Purchase Task)

Time frame:Baseline (Week 0) to Post-medication (Week 8)

change from baseline, improvement

Posted result

Group	Value (mean), number of cigarettes	95% CI
Semaglutide	-2.4	—
Sham/Placebo	-1.20	—

Secondary/registry result

Change in Daily Alcohol Use

Time frame:baseline (Week 0) to study endpoint (Week 10)

Alcohol consumption, change

change from baseline, improvement

Posted result

Group	Value (mean), daily drinks	95% CI
Semaglutide	-1.43	—
Sham/Placebo	-0.81	—

Secondary/registry result/low confidence

Change in Daily Cigarette Use

Time frame:baseline (Week 0) to study endpoint (Week 10)

Alcohol consumption, change

change from baseline, improvement

Posted result

Group	Value (mean), daily cigarettes	95% CI
Semaglutide	-2.48	—
Sham/Placebo	-1.30	—

Secondary/protocol endpoint

Change in Alcohol Demand (Alcohol Purchase Task)

Time frame:Baseline (Week 0) to post-treatment (Week 8)

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Cigarette Demand (Cigarette Purchase Task)

Time frame:Baseline (Week 0) to Post-medication (Week 8)

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Daily Alcohol Use

Time frame:baseline (Week 0) to study endpoint (Week 10)

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Daily Cigarette Use

Time frame:baseline (Week 0) to study endpoint (Week 10)

Alcohol consumption, change

change from baseline, improvement

Other/protocol endpoint

Change in Alcohol Elimination

Time frame:baseline (Week 0) to post-medication (Week 8)

change from baseline, descriptive

Other_pre_specified/registry result/low confidence

Change in Alcohol Elimination

Time frame:baseline (Week 0) to post-medication (Week 8)

change from baseline, descriptive

Publications (1)

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

Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial.
JAMA psychiatry2025 Apr 1PMID39937469doi:10.1001/jamapsychiatry.2024.4789via clinicaltrials gov reference derived + pubmed nct search

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.