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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
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.
Novo Nordisk Investigational Site
Groningen, Netherlands
Number of treatment emergent adverse events (TEAE) in Part 1
Number of events
Time frame: From time of dosing (day 1) until completion of follow-up visit (day 71)
Number of treatment emergent adverse events (TEAE) in Part 2
Number of events
Time frame: From first combination dosing (day 57) until completion of follow-up visit (day 148)
Area under the NNC0480-0389 plasma concentration-time curve from time
h∙nmol/L
Time frame: From baseline (day 1) to post treatment follow-up (day 71)
Maximum plasma concentration of NNC0480-0389 after administration of a single dose
nmol/L
Time frame: From baseline (day 1) to post treatment follow-up (day 71)
Area under the semaglutide plasma concentration time curve from time of dosing to infinity after administration of a single dose
h∙nmol/L
Time frame: From baseline (day 1) to post treatment follow-up (day 71)
The maximum concentration of semaglutide after administration of a single dose
nmol/L
Time frame: From baseline (day 1) to post treatment follow-up (day 71)
Area under the NNC0480-0389 plasma concentration-time curve from 0 to 168 hours after administration of the 4th dose of NNC0480-0389 in week 12
h∙nmol/L
Time frame: From administration of dose in week 12 (day 78) to day 85
Maximum plasma concentration of NNC0480-0389 after administration of the 4th dose of NNC0480-0389 in week 12
nmol/L
Time frame: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
Area under the semaglutide plasma concentration-time curve from 0-168 hours after administration of the 12th dose of semaglutide
h∙nmol/L
Time frame: From administration of dose in week 12 (day 78) to day 85
The maximum concentration of semaglutide after administration of the 12th dose of semaglutide
nmol/L
Time frame: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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