Obesity, Overweight
Conditions
Brief summary
The 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 your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
Interventions
DRUGNNC0638-0355
NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.
DRUGPlacebo (NNC0638-0355)
Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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
Key inclusion criteria * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally healthy 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. Key
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening. * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: 1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening 2. Parathyroid hormone (PTH) outside normal range at screening 3. Total calcium outside normal range at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAE) | From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks) | Measured as Number of events |
| Part B,C,D and E : Number of treatment emergent adverse events (TEAE) | From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks) | Measured as Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve | From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks) | Measured in hours\*nano mole per litre (h\*nmol/L) |
| Part A: Cmax; maximum observed NNC0638-0355 plasma concentration | From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks) | Measured in nano mole per litre (nmol/L) |
| Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve | From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks) | Measured in hour\*nano mole per litre (h\*nmol/L) |
| Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration | From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks) | Measured in nano mole per litre (nmol/L) |
Countries
Netherlands, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed