Obesity, Overweight
Conditions
Brief summary
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
Interventions
DRUGNNC0487-0111
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram 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 * HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Amylase equal to or greater than 2 times upper limit of normal at screening * Lipase equal to or greater than 2 times upper limit of normal at screening * Calcitonin equal to or greater than 50 ng/L at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PART A: Number of treatment emergent adverse events (TEAE) | From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 | Number of events |
| PARTS B to E: Number of treatment emergent adverse events (TEAE) | From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270 | Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From pre-dose on V33D1 until end of treatment (V34) up to 9 days | h\*nmol/L |
| PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 | h\*nmol/L |
| PART B to E: Relative change in body weight | From pre-dose on Day 1 until end of treatment (V34) up to Day 255 | Percentage (%) |
| PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax | From pre-dose on V33D1 until end of study visit (V37) up to 24 days | nmol/L |
| PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax | From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 | nmol/L |
Countries
United States
Outcome results
None listed