The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Novo Nordisk INvestigational Site
San Antonio, Texas, United States
PART A: Number of treatment emergent adverse events (TEAE)
Number of events
Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
PARTS B to E: Number of treatment emergent adverse events (TEAE)
Number of events
Time frame: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
h\*nmol/L
Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
nmol/L
Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose
h\*nmol/L
Time frame: From pre-dose on V33D1 until end of treatment (V34) up to 9 days
PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax
nmol/L
Time frame: From pre-dose on V33D1 until end of study visit (V37) up to 24 days
PART B to E: Relative change in body weight
Percentage (%)
Time frame: From pre-dose on Day 1 until end of treatment (V34) up to Day 255
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