Clinical Research Directory

Inclusion Criteria: * Age 18-75 years * BMI ≥ 30 kg/m² * History of at least one attempt to lose body weight Exclusion Criteria: * A self-reported change in body weight ≥ 5% within the last 90 days prior to the screening visit * Treatment with any therapy, including endoscopic procedures and/or medication (e.g. liraglutide, bupropion/naltrexone and orlistat), intended for weight management within 90 days prior to screening * Previous, current, or planned (during the trial period) obesity treatment with surgery or a weight loss device \< 1 year prior to screening * Glycated haemoglobin (HbA1c) ≥ 48 mmol/mol * History of type 1 diabetes or type 2 diabetes * Treatment with glucose-lowering agents within 90 days prior to screening * Compromised kidney function (estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2) at screening * Known liver disease (except for non-alcoholic fatty liver disease) and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening * History of acute and/or chronic pancreatitis * History and/or family history of medullary carcinoma and/or multiple endocrine neoplasia syndrome * Inflammatory bowel disease * Any history of colon cancer or intestinal polyps * Any history of intestinal stenosis * History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least five years * Uncontrolled thyroid disease as per discretion of the investigators * Any of the following: myocardial infarction, stroke, hospitalisation for angina and transient ischaemic attack within the last 60 days prior to screening * Class IV heart failure according to the New York Heart Association * Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardise the participant's safety during the trial * Alcohol/drug abuse as per discretion of the investigators * Known or suspected hypersensitivity to the trial product or related products * Previous treatment with the trial product * Administration of an investigational drug within 90 days prior to screening * Simultaneous participation in any other clinical intervention trial * Mental incapacity or language barriers that preclude adequate understanding or cooperation, or unwillingness to comply with trial requirements * Use of GLP-1RA, GLP-2RA, dipeptidyl peptidase 4 (DPP) inhibitors, human growth hormone, somatostatin, or analogues thereof, within three months prior to screening * Known radiation enteritis or significant villous atrophy, e.g., due to active coeliac disease or inflammatory bowel disease * Regarding fertile men and women: * Women who are pregnant, breastfeeding, intend to become pregnant or are of childbearing potential will not be included in the study * Sterilised or postmenopausal women (\> 12 months amenorrhoea or females ≥ 60 years of age) can be included * The following contraceptive methods are considered adequate for study enrolment of male participants: Surgically sterilised or willing to refrain from sexual intercourse from screening and until completion of the follow-up visit, or, if sexually active, condom usage and partner-practised contraception during the trial, i.e., from screening to the last visit