STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Overweight or Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Intervention: Semaglutide; Placebo (semaglutide)
Intervention description: Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.; Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
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: 1961.0
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. The weight loss in participants taking semaglutide (a new medicine) will be
      compared to the weight loss of participants 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 you can do to lose weight. Participants will either get
      semaglutide or "dummy" medicine - which treatment participants get, is decided by chance.
      Participants will need to take 1 injection once a week. The study medicine is injected with a
      thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A
      main phase and an extension phase.The main phase will last for about 1.5 years. Participants
      will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase:
      Approximately 300 participants will continue in the extension phase in the following
      countries only: Canada, Germany, the UK and selected sites in the US and Japan. These
      participants will be in the study for about 2.5 years.They will not receive treatment, but
      will attend another 5 follow-up visits with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

        Main phase:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to
             27.0 kg/sqm with the presence of at least one of the following weight-related
             comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep
             apnoea or cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Extension phase:

          -  Informed consent for the extension phase obtained before any trial related activities
             for the extension phase

          -  On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg
             semaglutide once-weekly or semaglutide placebo

        Exclusion Criteria:

        Main phase:

          -  Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured
             by the central laboratory at screening

          -  A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records

        Extension phase:

          -  Female who is pregnant or intends to become pregnant during the extension phase

          -  Any disorder, unwillingness or inability, not covered by any of the other exclusion
             criteria, which in the investigator's opinion, might jeopardise the subject's
             compliance with the extension of the trial