Obesity, Overweight
Conditions
Brief summary
The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.
Interventions
DRUGNNC0721-8060
NNC0721-8060 will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
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
Yes
Inclusion criteria
* Male or female (sex at birth). * Age 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator. * Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous randomisation in this study. * History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions. * Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception. * Current participation (signed informed consent) in any other interventional clinical study. * Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening. * Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole \[mmol/mol\]) at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of treatment emergent adverse events (TEAE) | From Day 1 to Day 57 | Measured as number of events. |
| Part C: Change from baseline in body weight | From Day 1 to Day 85 | Measured as percentage change in body weight. |
| Part A: Number of treatment emergent adverse events (TEAE) | From Day 1 to Day 36 | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: AUC- Area under the NNC0721-8060 plasma concentration time-curve | From Day 1 to Day 57 | Measured as h\*nmol/L. |
| Part B: Cmax- Maximum observed plasma concentration of NNC0721-8060 | From Day 1 to Day 57 | Measured as nmol/L. |
| Part C: AUC- Area under the NNC0721-8060 plasma concentration time-curve | From Day 1 to Day 113 | Measured as h\*nmol/L. |
| Part C: Number of treatment emergent adverse events (TEAE) | From Day 1 to Day 113 | Measured as number of events. |
| Part A: AUC- Area under the NNC0721-8060 plasma concentration time-curve | From Day 1 to Day 36 | Measured as hour nanomoles per litre (h\*nmol/L). |
| Part C: Cmax- Maximum observed plasma concentration of NNC0721-8060 | From Day 1 to Day 113 | Measured as nmol/L. |
| Part A: Cmax- Maximum observed plasma concentration of NNC0721-8060 | From Day 1 to Day 36 | Measured as nanomoles per litre (nmol/L). |
Countries
United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed