Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.
Interventions
DRUGNNC0174-0833
Doses of NNC0174-0833, dosed either once daily or once weekly
DRUGPlacebo
Dosed either once daily or once weekly
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator
Exclusion criteria
* History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention * History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure * History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis) * Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) of childbearing potential (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (TEAEs) | From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The area under the NNC0174-0833 plasma concentration-time curve | From time 0 to 24 hours at steady state | \[only applicable for once daily dosing\] |
| The maximum concentration of NNC0174-0833 in plasma at steady state | Day 1; Day 57 | — |
Countries
United States
Outcome results
None listed