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

Inclusion Criteria:

• Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0kg/m2 with the presence of at least one of the following comorbidities: hypertensionor dyslipidemia (treated or untreated).

• A female participant is eligible to participate if she is:

• A woman of nonchildbearing potential. OR

• A woman of childbearing potential (WOCBP) who is not pregnant, does not intendto be pregnant, not lactating and is willing to use highly effectivecontraceptive methods (as required by local regulation or practice) throughoutthe trial and for 10 weeks after the last injection of the investigationalmedicinal product (IMP).

• Ability to comply with the protocol requirements including self-administration ofIMP with vial and syringe.

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 alternativeremedies (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 abody weight loss device. However, liposuction or surgical removal of fat depots morethan 1 year prior to screening or device-based interventions (e.g. sleeve, bandingor similar) that have been removed more than 6 months prior to screening, areallowed.

• 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 theChronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured atscreening.

• Impaired liver function, defined as alanine aminotransferase and/or aspartateaminotransferase ≥2.0 times or bilirubin >1.5 times upper normal limit, measured atscreening.

• Presence or history of acute or chronic pancreatitis.

• Known clinically significant gastric emptying abnormality (for example, severegastroparesis or gastric outlet obstruction) or chronic treatment that affectsgastrointestinal (GI) motility.

• Presence or history of cardiovascular disease including stable and unstable anginapectoris, myocardial infarction, transient ischemic attack, stroke, cardiacdecompensation.

• Presence or history of clinically significant arrhythmias or clinically significantconduction 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.