Clinical trial
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
Opening soon · Phase 1 · 1 countries · Registry ID NCT07587710
Opening soonPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity
Full registry 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.
Treatments and study arms
NNC0487-0111
Drug
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Primary outcomes
AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single doseFrom pre-dose on Day 1 up to Day 28
Measured as hours\*nanomole per liter (nmol\*h/L)