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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Semaglutide for Alcohol Use Disorder

NCTNCT05520775 (opens ClinicalTrials.gov in a new tab)Other id21-1689Other idR21AA026931-02

Overview

Status
Completed
Phase
Phase 2
Enrollment
48 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
2 Sept 2022
Primary completion
12 Apr 2024
Completion
19 Apr 2024
First posted
30 Aug 2022
Last update posted
2 Apr 2025
Conditions
Alcohol Use Disorder · Cigarette Smoking

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 2

    Semaglutide for Alcohol Use Disorder

    NCT05520775

    2 Sept 2022 to 19 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).

Interventions

  • SemaglutideDrug
  • Sham/placeboDrug

Arms2

  • Experimental

    Semaglutide

    Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.

  • Sham comparator

    Sham/Placebo

    Participants will receive sham subcutaneous injections over 9 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Alcohol Consumed

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

    Registry description

    Estimated grams of ethanol consumed.

  2. Change in Breath Alcohol Concentration

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

    Registry description

    Peak breath alcohol concentration following an alcohol self-administration procedure.

Secondary outcomes(6)
  1. Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

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

    Registry description

    Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being "not at all" and 10 being "extremely". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.

  2. Change in Subjective Sedation (Biphasic Alcohol Effects Scale)

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

    Registry description

    Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 "not at all" through 10 "extremely". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.

  3. Change in Alcohol Demand (Alcohol Purchase Task)

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

    Registry description

    The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.

  4. Change in Cigarette Demand (Cigarette Purchase Task)

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

    Registry description

    Self-report cigarette demand as measured by the Cigarette Purchase Task. Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.

  5. Change in Daily Alcohol Use

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

    Registry description

    Self-reported drinks per day averaged across study week.

  6. Change in Daily Cigarette Use

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

    Registry description

    Self-reported cigarettes per day

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (Week 0) to post-medication (Week 8)

Change in Alcohol Consumed

GroupValue (grams)Spread
Semaglutide-32.7227.98
Sham/Placebo-6.9524.49
Primary outcomeMean· Baseline (Week 0) to post-medication (Week 8)

Change in Breath Alcohol Concentration

GroupValue (g/dl)Spread
Semaglutide-0.0340.045
Sham/Placebo-0.0160.047
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline (Week 0) to post-treatment (Week 8)

Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

GroupValue (Score on a scale)Spread
Semaglutide.4512.82
Sham/Placebo-1.2813.49
Secondary outcomeMean· baseline (Week 0) to post-medication (Week 8)

Change in Subjective Sedation (Biphasic Alcohol Effects Scale)

GroupValue (Score on a scale)Spread
Semaglutide0.1410.69
Sham/Placebo-3.227.89
Secondary outcomeMean· Baseline (Week 0) to post-treatment (Week 8)

Change in Alcohol Demand (Alcohol Purchase Task)

GroupValue (number of drinks)Spread
Semaglutide-2.913.73
Sham/Placebo-2.907.82
Secondary outcomeMean· Baseline (Week 0) to Post-medication (Week 8)

Change in Cigarette Demand (Cigarette Purchase Task)

GroupValue (number of cigarettes)Spread
Semaglutide-2.42.61
Sham/Placebo-1.202.17
Secondary outcomeMean· baseline (Week 0) to study endpoint (Week 10)

Change in Daily Alcohol Use

GroupValue (daily drinks)Spread
Semaglutide-1.431.51
Sham/Placebo-0.812.45
Secondary outcomeMean· baseline (Week 0) to study endpoint (Week 10)

Change in Daily Cigarette Use

GroupValue (daily cigarettes)Spread
Semaglutide-2.484.22
Sham/Placebo-1.302.10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutideParticipants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks. Semaglutide: Semaglutide (subcutaneous)0 / 240 / 2422 / 24
Sham/PlaceboParticipants will receive sham subcutaneous injections over 9 weeks. Sham/placebo: Sham subcutaneous injection0 / 240 / 2418 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

8 results

Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial.

Hendershot et al. 2025JAMA psychiatrycited by 213

PMID 39937469PMC11822619DOI 10.1001/jamapsychiatry.2024.4789PUB-39937469

CC BY8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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)

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