A study to test whether BI 456906 helps people living with overweight or obesity who also have diabetes to lose weight

Prior treatment

• Body weight change (self-reported) of >5% within 3 months before screening
• Treatment with any medication for the indication obesity within 3 months before screening
• Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before the screening visit up to and including the randomisation visit (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and dipeptidyl peptidase 4 inhibitor [DPP-4i])

Other illness

• Heart failure (HF) with NYHA class IV
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)

Lab values

• QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
• History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x ULN as measured by the central laboratory at screening

Other

• Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
• Further exclusion criteria apply.

• Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
• BMI ≥27 kg/m^2 at screening
• Diagnosed with T2DM (defined as glycosylated haemoglobin A1c [HbA1c] ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
• HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening
• Currently treated for T2DM with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Further inclusion criteria apply.