Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (semaglutide); Liraglutide; Placebo (liraglutide)
Intervention description: Dose gradually increased to 2.4 mg administered once weekly for 68 weeks; Administered once weekly for 68 weeks; Dose gradually increased to 3.0 mg administered once daily for 68 weeks; Administered once daily for 68 weeks
Intervention MeSH terms: Liraglutide
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: Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency.
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at participants' body weight from the start to the end of the study. The
      study will last for about 1½ years. This is to compare the effect on body weight in people
      taking semaglutide once a week or people taking liraglutide once every day. Participants will
      either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by
      chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to
      take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy"
      medicine will need to take 1 injection once daily. The study medicine is injected with a thin
      needle in a skin fold in the stomach, thigh or upper arm. During the study participants will
      have talks with study staff about eating healthy food and how to be more physically active.
      Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the
      clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the
      visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant
      during the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18 years or older at the time of signing informed consent

          -  Body mass index (BMI) equal to or above 30.0 kg/m^2 or equal to or above 27.0 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

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at
             screening

          -  History of type 1 or type 2 diabetes mellitus

          -  A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records