First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes
Condition: Healthy Volunteers; Overweight; Obesity; Diabetes Mellitus, Type 2
MeSH terms: Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate how safe, and how well tolerated, the new study
      drug NNC0480-0389 is when it is given together with semaglutide. This will be investigated in
      healthy participants, participants with high bodyweight and participants with type 2 diabetes
      (T2D). NNC0480-0389 has not been given to humans before. It has been previously tested in the
      laboratory and on animals. NNC0480-0389 will be tested at various dose levels. Semaglutide is
      a new approved drug and is already available on the market for treatment of diabetes. It will
      also be investigated how quickly and to what extent NNC0480-0389 and semaglutide are taken up
      and eliminated from the body. This is called pharmacokinetics. The effect of NNC0480-0389
      given together with semaglutide will also be investigated on body weight and glucose levels
      in the blood. This is called pharmacodynamics. The effects of NNC0480-0389 and/or semaglutide
      will be compared to the effects of a placebo. A placebo is a "dummy" medicine without any
      active medicine. Placebo looks like NNC0480-0389 and/or semaglutide. There are 4
      possibilities for which treatment participants will get; participants will receive
      NNC0480-0389 and semaglutide or NNC0480-0389 and placebo or placebo with semaglutide, or
      placebo with placebo. Participants and the responsible doctor will not know which combination
      participants will be given. This is called a double-blinded study. However, this information
      can be looked up during the study if it is important for participants' health. The study
      medicines will be given as injections under the skin. Participants will be in the study for
      about 25 weeks.
    


Intervention name(s): NNC0480-0389; Semaglutide; Placebo (NNC0480-0389); Placebo (semaglutide)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Part 1: A single dose of NNC0480-0389, dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.; Part 1: Single dose of semaglutide (0.5 mg). Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.; Placebo for NNC0480-0389. Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.; Part 1: Single dose of placebo (semaglutide) (0.5 mg). Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1: Single ascending dose Part 2: Multiple ascending dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment