A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes

Ki vehet részt

• Aged 18 years or older at the time of signing informed consent
• Body mass index:
• at least 28 kg/m²; or
• at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence
• Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation
• Participants with type 2 diabetes mellitus must:
• have been diagnosed at least 6 months before informed consent
• have HbA1c between 6.0% and 10.0% at Screening; and
• be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening
• At least one previous self-reported unsuccessful attempt to lose body weight
• Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation
• Able to provide signed informed consent

Ki nem vehet részt

• Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening
• Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening
• Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract
• Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening
• Previous or planned surgical treatment for obesity
• Known or suspected drug abuse or alcohol abuse
• Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks
• Weight-management treatment within 3 months before Randomisation
• Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation
• Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation
• Concomitant medication that may increase risk, affect study results, or interfere with study participation
• Participation in another clinical study within 30 days before Screening
• Previous randomisation in the present study
• Obesity primarily caused by another endocrine disorder
• Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol
• Clinically important disease or disorder that may place the participant at risk or interfere with study participation
• Use of insulin therapy for type 2 diabetes mellitus
• Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher
• History of psychosis or active symptomatic bipolar disorder
• Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt
• Known hypersensitivity to AZD6234
• Any other condition that, in the Investigator's judgement, makes participation inappropriate
• Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin
• Clinically significant gastric-emptying abnormality requiring treatment
• Uncontrolled hypothyroidism or hyperthyroidism
• Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants
• Involvement in the planning and/or conduct of the study
• Unlikely or unable to comply with study procedures, restrictions, or requirements
• Currently pregnant or breastfeeding