Obesity, Overweight
Conditions
Brief summary
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
Interventions
DRUGNNC0487-0111 (formulation D)
Participants will receive NNC0487-0111 (formulation D) tablet once daily.
DRUGNNC0487-0111 (formulation C)
Participants will receive NNC0487-0111 (formulation C) tablet once daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Single-blinded to the investigator (to the formulation).
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18-64 years (both inclusive) * Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion criteria
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 ng/mL (30 Nanometer (nM)) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Calcitonin greater than or equal to (≥) 50 pg/mL at screening * Amylase greater than or equal to (≥) 2 times upper limit of normal * Lipase greater than or equal to (≥) 2 times upper limit of normal * Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state | From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 | Measured as hours\*nanomoles per liter (h\*nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state | From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 | Measured as hours |
| Phase B: The area under the NNC0487-0111 plasma concentration-time curve | From pre-dose to after dosing on day 132 | Measured as h\*nmol/L |
| Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose | From pre-dose to after dosing on day 132 | Measured as nmol/L |
| Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state | From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 | Measured as nanomoles per liter (nmol/L) |
| Phase B:The terminal half-life of NNC0487-0111 after the last dose | From pre-dose on day 132 until completion of the end of study visit (day 153) | Measured as hours |
| Number of treatment emergent adverse events (TEAE) | From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153) | Measured as number of events |
| Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose | From pre-dose to after dosing on day 132 | Measured as hours |
Countries
United States
Outcome results
None listed