Overweight, Obesity
Conditions
Brief summary
The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.
Interventions
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Sponsors
Study design
Eligibility
Inclusion criteria
* Male or female (sex at birth). * Age 18-80 years (both inclusive) at the time of signing informed consent. * Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞: 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 up to Day 28 | Measured as hours\*nanomole per liter (nmol\*h/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose | From pre-dose on Day 1 until Day 5 | Measured as nanomoles per liter (nmol/L) |
| tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose | From pre-dose on Day 1 until Day 5 | Measured as hour |
| t½,: Terminal half-life for NNC0487-0111 after a single dose | From pre-dose on Day 1 up to Day 28 | Measured as hour |
| Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose | From pre-dose on Day 1 up to Day 28 | Liter |
| CL/F: Apparent clearance of NNC0487-0111 after a single dose | From pre-dose on Day 1 up to Day 28 | Measured as liter per hour (L/h) |
| Number of treatment emergent adverse events (TEAEs) | From pre-dose on Day 1 up to Day 28 | Measured as number of events |
Countries
Slovakia
Contacts
Novo Nordisk A/S