Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: NNC0174-0833; Placebo (NNC0174-0833); Liraglutide 3.0 mg; Placebo (Liraglutide 3.0 mg)
Intervention description: Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.; Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.; Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.; Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
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: 706.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in body weight in people taking NNC0174-0833, liraglutide
      and "dummy" medicine, from the start to the end of the study. As well as 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 take
      NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided
      by chance. Participants will need to take one injection once a week or once a day, depending
      on the treatment. The study medicine is injected with a thin needle in a skin fold in the
      stomach, thigh or upper arm. The study will last for about 8 months. Participants will have
      12 clinic visits with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older at the time of signing the informed consent.

          -  Female subject of non-childbearing potential or Male subject who is surgically
             sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as
             required by local regulation or practice) throughout the trial (until 'end of trial').

          -  BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the
             presence of at least one of the following weight-related comorbidities (treated or
             untreated): hypertension or dyslipidaemia (to be assessed at the investigator's
             discretion).

        Exclusion Criteria:

          -  HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central
             laboratory at screening.

          -  A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior
             to screening irrespective of medical records.