Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

Exclusion Criteria

• •Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening.
• •History of type 1 or type 2 diabetes mellitus.
• •Treatment with glucose lowering agent(s) within 90 days prior to screening.
• •A self-reported change in body weight \>5% within 90 days prior to screening.
• •Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening.
• •Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g. sleeve, banding or similar) that have been removed more than 6 months prior to screening, are allowed.
• •Uncontrolled thyroid disease defined as thyroid stimulating hormone \>4.20 mIU/L or \<0.27 mIU/L as measured by the central laboratory at screening.
• •Lifetime history of a suicidal attempt.
• •History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
• •Estimated glomerular filtration rate value \<60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening.
• •Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin \>1.5 times upper normal limit, measured at screening.
• •Presence or history of acute or chronic pancreatitis.
• •Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility.
• •Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation.
• •Presence or history of clinically significant arrhythmias or clinically significant conduction disorders.
• •Known or suspected hypersensitivity to amylin analogs or related products.
• •History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening.
• •Known or suspected abuse of alcohol or recreational drugs.
• •Participant previously treated with petrelintide or any other amylin analog.