This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
ICON Early Phase Services, LLC
San Antonio, Texas, United States
ICON Early Phase Services, LLC
Salt Lake City, Utah, United States
Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
Number of events
Time frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
Part B: Number of treatment emergent adverse events (TEAE)
Number of events
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve
measured in hour\*nanomoles per liter (h\*nmol/L).
Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part A: Cmax; maximum observed NNC0174 1213 plasma concentration
measured in nanomoles per liter (nmol/L).
Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve
measured in h\*nmol/L.
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Part B: Cmax; maximum observed NNC0174 1213 plasma concentration
measured in nmol/L.
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
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