Dapiglutide for the Treatment of Obesity (DREAM)

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