A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC0487-0111.
- Who it may be relevant to
- Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study Investigating the Pharmacokinetic Properties, Safety and Tolerability of NNC0487-0111 in Participants With Various Degrees of Hepatic Impairment and Participants With Normal Hepatic Function
Overview
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
- Drug NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Primary outcome measures
- AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose [Time frame: From pre-dose on Day 1 up to Day 28]
Secondary outcome measures (6)
- Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose [Time frame: From pre-dose on Day 1 until Day 5]
- tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose [Time frame: From pre-dose on Day 1 until Day 5]
- t½,: Terminal half-life for NNC0487-0111 after a single dose [Time frame: From pre-dose on Day 1 up to Day 28]
- Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose [Time frame: From pre-dose on Day 1 up to Day 28]
- CL/F: Apparent clearance of NNC0487-0111 after a single dose [Time frame: From pre-dose on Day 1 up to Day 28]
- Number of treatment emergent adverse events (TEAEs) [Time frame: From pre-dose on Day 1 up to Day 28]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovakia · 2 centers
- Summit Clinical Research s.r.o. — Bratislava
- Summit Clinical Research s.r.o. — Malacky
Identifiers
NCT: NCT07587710 · NN9490-8156 · U1111-1320-4875 · 2025-521647-20