A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
Status:
Not yet recruiting
Trial end date:
2023-06-05
Target enrollment:
Participant gender:
Summary
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin
and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the
body to feel full. This study tests if the study medicine is safe and to find out how the
medicine works in humans. This study also look at how the study medicine affects body weight
and how to improve the treatment of people with overweight, obesity or related diseases.
This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five
groups, one additional group may be added. Each group will include 8 participants, with 6
participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants
randomised to receive placebo. The dosing within each group will be sequential, i.e., 2
sentinel participants (1 on active and 1 on placebo).
Part B: This is planned to consist of three groups, one additional group may be added. Each
group will include 12 participants, with 9 participants being randomised to receive
NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The
dosing within each group will be sequential. For the first group, 4 sentinel participants (3
on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days
(168 hours), before dosing of the remaining participants in the group will be initiated. For
the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed
followed by a safety observation period of at least 36 hours before dosing of the remaining
participants in the group will be initiated.
Part C and D are matching regarding planned visits and procedures, but the study
interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each
part is planned to consist of one group, although one additional group may be added. Each
group will include 20 participants, with 16 participants being randomised to receive active
treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The
dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will
be dosed followed by a safety observation period of at least 36 hours before dosing of the
remaining participants in the cohort will be initiated. The remaining participants will be
dosed in smaller groups of 8 participants separated by a safety observation period of at
least 36 hours.
A safety evaluation will be made between dosing of participants within a group and before
moving on to a higher dose.