A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range (STEP12)
Overweight, Obesity
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years at the time of signing informed consent. Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and greater than 30 kg/m^2, with or without weight related complications at screening. History of at least one self-reported unsuccessful dietary effort to lose body weight. For participants with T2D at screening: - Diagnosed with T2D greater than or equal to 180 days prior to the day of screening Treated with either: Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label. Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening. Exclusion Criteria: A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records. Treatment with any medication for the indication of obesity within the past 90 days before screening. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. For participants without T2D at screening: - HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory. For participants with T2D at screening: Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification 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.
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Semaglutide 2.4 milligram (mg)
Placebo
Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.
Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.