A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): NNC0487-0111 A; NNC0487-0111 B; Placebo B (NNC0487-0111 B); Placebo A (NNC0487-0111 A)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Participants will receive NNC0487-0111 A tablet once daily.; Participants will receive NNC0487-0111 B tablet once daily.; Participants will receive placebo matched to NNC0487-0111 B tablet once daily.; Participants will receive placebo matched to NNC0487-0111 A tablet once daily.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight