Phase 2 · Semaglutide

NCT05520775 trial results

Human Laboratory Screening of Semaglutide for Alcohol Use Disorder

Change in Alcohol Consumed (grams), Baseline (Week 0) to post-medication (Week 8). Semaglutide: -32.72; Sham/Placebo: -6.95.

Participants
48
Status
completed
Completed
2024-04-19
Sponsor
University of North Carolina, Chapel Hill

As posted on ClinicalTrials.gov (NCT05520775), updated at source Apr 2, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT05520775 measured first

Change in Alcohol Consumedgrams · Baseline (Week 0) to post-medication (Week 8) · mean
Semaglutiden=13Sham/Placebon=12
-32.72(27.98)-6.95(24.49)
Change in Breath Alcohol Concentrationg/dl · Baseline (Week 0) to post-medication (Week 8) · mean
Semaglutiden=13Sham/Placebon=12
-0.034(0.045)-0.016(0.047)
Side effects by arm

Side effects in NCT05520775

Percent of participants affected, From the Baseline medical visit through follow-up, a total of up to 12 weeks.. The most common events the registry lists.

EventSemaglutideSham/Placebo
Any serious event0%0%
Decreased Appetite75%41.7%
Nausea70.8%16.7%
Constipation50%8.3%
Headache50%20.8%
Diarrhea41.7%37.5%
Fatigue37.5%25%
Nervousness/Anxiety8.3%29.2%
Abdominal Pain25%16.7%
Insomnia12.5%20.8%
Increased Appetite8.3%16.7%
Dizziness12.5%8.3%
Vomiting8.3%12.5%
Depression4.2%8.3%
Increased Libido4.2%8.3%
Secondary outcomes

What else it measured

Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)Score on a scale · Baseline (Week 0) to post-treatment (Week 8) · mean
Semaglutiden=22Sham/Placebon=18
.45(12.82)-1.28(13.49)
Change in Subjective Sedation (Biphasic Alcohol Effects Scale)Score on a scale · baseline (Week 0) to post-medication (Week 8) · mean
Semaglutiden=22Sham/Placebon=18
0.14(10.69)-3.22(7.89)
Change in Alcohol Demand (Alcohol Purchase Task)number of drinks · Baseline (Week 0) to post-treatment (Week 8) · mean
Semaglutiden=23Sham/Placebon=20
-2.91(3.73)-2.90(7.82)
Change in Cigarette Demand (Cigarette Purchase Task)number of cigarettes · Baseline (Week 0) to Post-medication (Week 8) · mean
Semaglutiden=5Sham/Placebon=4
-2.4(2.61)-1.20(2.17)
Change in Daily Alcohol Usedaily drinks · baseline (Week 0) to study endpoint (Week 10) · mean
Semaglutiden=21Sham/Placebon=18
-1.43(1.51)-0.81(2.45)
Change in Daily Cigarette Usedaily cigarettes · baseline (Week 0) to study endpoint (Week 10) · mean
Semaglutiden=5Sham/Placebon=4
-2.48(4.22)-1.30(2.10)
The trial

How NCT05520775 was run

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).

  • Semaglutide: Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.
  • Sham/Placebo: Participants will receive sham subcutaneous injections over 9 weeks.
Who could join the trial

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:...

Published papers

Papers from NCT05520775

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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