NCT05530577 trial results

Inclusion Criteria: * Age 21-65 * Smoking 5+ cigarettes per day (on average) over the past year, with no period of abstinence \> 90 days * Biochemical verification of smoking status, based on expired CO \> 8 at baseline * Willingness to take study medication and complete study procedures * Willingness to complete lab sessions involving cigarette smoking * Ability to communicate in English Exclusion Criteria: * Regular use of electronic nicotine delivery systems (ENDS/vaping), cigars, chewing tobacco or snuff, based on at least weekly use in the past 30 days * Past 30-day use of nicotine replacement therapies/products * 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 * Current engagement in alcohol or smoking cessation treatments, or currently engaged in intentional efforts to quit cigarette 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) * Meeting criteria for current alcohol use disorder (AUD) or other substance use disorder (with the exception of tobacco or mild cannabis use 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...