What NCT05520775 measured first
| Semaglutiden=13 | Sham/Placebon=12 |
|---|---|
| -32.72(27.98) | -6.95(24.49) |
| Semaglutiden=13 | Sham/Placebon=12 |
|---|---|
| -0.034(0.045) | -0.016(0.047) |
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.
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.
| Semaglutiden=13 | Sham/Placebon=12 |
|---|---|
| -32.72(27.98) | -6.95(24.49) |
| Semaglutiden=13 | Sham/Placebon=12 |
|---|---|
| -0.034(0.045) | -0.016(0.047) |
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.
| Event | Semaglutide | Sham/Placebo |
|---|---|---|
| Any serious event | 0% | 0% |
| Decreased Appetite | 75% | 41.7% |
| Nausea | 70.8% | 16.7% |
| Constipation | 50% | 8.3% |
| Headache | 50% | 20.8% |
| Diarrhea | 41.7% | 37.5% |
| Fatigue | 37.5% | 25% |
| Nervousness/Anxiety | 8.3% | 29.2% |
| Abdominal Pain | 25% | 16.7% |
| Insomnia | 12.5% | 20.8% |
| Increased Appetite | 8.3% | 16.7% |
| Dizziness | 12.5% | 8.3% |
| Vomiting | 8.3% | 12.5% |
| Depression | 4.2% | 8.3% |
| Increased Libido | 4.2% | 8.3% |
| Semaglutiden=22 | Sham/Placebon=18 |
|---|---|
| .45(12.82) | -1.28(13.49) |
| Semaglutiden=22 | Sham/Placebon=18 |
|---|---|
| 0.14(10.69) | -3.22(7.89) |
| Semaglutiden=23 | Sham/Placebon=20 |
|---|---|
| -2.91(3.73) | -2.90(7.82) |
| Semaglutiden=5 | Sham/Placebon=4 |
|---|---|
| -2.4(2.61) | -1.20(2.17) |
| Semaglutiden=21 | Sham/Placebon=18 |
|---|---|
| -1.43(1.51) | -0.81(2.45) |
| Semaglutiden=5 | Sham/Placebon=4 |
|---|---|
| -2.48(4.22) | -1.30(2.10) |
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).
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:...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.