A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, participants will receive semaglutide and NNC0480-0389 together at the same
      time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new
      potential medicine. Giving the medicines at the same time will be investigated once by using
      two separate syringes and once by using only one syringe containing both medicines
      ("co-formulation"). The co-formulation will be given together with an injection of placebo.
      Both medicines are tested for the treatment of type 2 diabetes. Giving the two complementary
      medicines at the same time is intended to lower blood sugar in people with type 2 diabetes.
      NNC0480-0389, in combination with semaglutide, is already being investigated in an ongoing
      human clinical study.

      The aim of this study is to compare the amount of medicine (semaglutide and NNC0480-0389) in
      the blood: after participants received the medicines at the same time (0.5 mg semaglutide and
      5 mg NNC0480-0389) using only one syringe (co-formulation)after participants received the
      medicines separately using two syringes.

      For this purpose, the amount of semaglutide and NNC0480-0389 in the blood will be measured
      after participants received the medicines in co-formulation and after participants received
      the medicines using separate syringes. There will be two treatment periods: One period where
      participants receive the two medicines as two separate injections and another period where
      participants receive the two medicines in one injection (co-formulation), together with an
      injection of placebo. It will be randomly determined in which order participants will receive
      the 2 treatments (separate injections first or co-formulation first).

      For both treatments the study medicines will be injected into a skin fold in the left and
      right stomach using a thin needle.Giving the medicines in the two treatment periods will take
      place at an interval of at least 8 weeks. The study can last for up to 19 weeks for each
      participant. This includes a screening period (up to 4 weeks), two treatment periods (5 weeks
      each) and a washout period (3 - 5 weeks). The washout period ensures that the given
      treatments and their effects have disappeared from the body. Participants will not receive
      any study medicines during this time. Participants will have 21 clinic visits. Some of the
      visits include overnight stays. Participants will have blood tests at every clinic visit.

      For 4 visits (Visits 2, 11, 12 and 21; Day 1 and 36 of each period) participants must not
      have had any food or drink (water is allowed) for up to 8 hours before participantsr body
      weight is measured. Participants must be healthy and have a body mass index (BMI) between
      20.0 and 29.9 kg/m2. If participants are a woman participants can only take part in this
      clinical study, if participants cannot get pregnant, for example, after menopause. A hormone
      test will be done to confirm this.
    


Intervention name(s): Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL; semaglutide 1.34 mg/mL (placebo); Semaglutide 1.34 mg/mL; NNC0480-0389 A 10 mg/mL
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.; Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.; The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.; The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment