STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (semaglutide)
Intervention description: Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.; Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in participants' body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. In addition to taking the medicine,
      participants will have talks with study staff about healthy food choices, how to be more
      physically active and what participants can do to lose weight. Participants will either get
      semaglutide or "dummy" medicine - which treatment participants get is decided by chance.
      Participants are three times as likely to get semaglutide as "dummy" medicine. Participants
      will need to take 1 injection once a week. The study medicine is injected with a thin needle
      in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a
      half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age more than or equal to 18 years at the time of signing informed
             consent

          -  BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related
             comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with
             more than or equal to 1 weight related comorbidity (treated or untreated) according to
             the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia
             (Japan only: or T2D)

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

          -  For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or
             equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol)
             (both inclusive)

        Exclusion Criteria:

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records

          -  For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%)
             as measured by the central laboratory at screening

          -  For subjects with T2D at screening (Japan only): a) Renal impairment measured as
             estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2
             (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2
             inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI)
             creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012
             by the central laboratory at screening. b) Uncontrolled and potentially unstable
             diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated
             fundus examination performed by an ophthalmologist or another suitably qualified
             health care provider within the past 90 days prior to screening or in the period
             between screening and randomisation