Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity (STEP 7)

This is an interventional treatment trial for Overweight Read More

Inclusion Criteria:

• Male or female, age 18 years or older at the time of signing informed consent
• History of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects without T2D at screening:

• Body mass index (BMI) of :
• greater than or equal to 30 kg/m^2
• greater than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For subjects with T2D at screening:

• Diagnosed with T2D above or equal to 180 days prior to the day of screening
• Treated with either:
• diet and exercise alone or
• stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label
• HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
• BMI greater than or equal to 27 kg/m^2

Exclusion Criteria:

• A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

For subjects without T2D at screening:

- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening

For subjects with T2D at screening:

• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.