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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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07587710
Enrollment
35
Registered
2026-05-14
Start date
2026-05-13
Completion date
2027-12-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Obesity

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

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
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 28Measured as hours\*nanomole per liter (nmol\*h/L)

Secondary

MeasureTime frameDescription
Cmax: Maximum observed plasma NNC0487-0111 concentration after a single doseFrom pre-dose on Day 1 until Day 5Measured as nanomoles per liter (nmol/L)
tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single doseFrom pre-dose on Day 1 until Day 5Measured as hour
t½,: Terminal half-life for NNC0487-0111 after a single doseFrom pre-dose on Day 1 up to Day 28Measured as hour
Vz/F: Apparent volume of distribution of NNC0487-0111 after a single doseFrom pre-dose on Day 1 up to Day 28Liter
CL/F: Apparent clearance of NNC0487-0111 after a single doseFrom pre-dose on Day 1 up to Day 28Measured as liter per hour (L/h)
Number of treatment emergent adverse events (TEAEs)From pre-dose on Day 1 up to Day 28Measured as number of events

Countries

Slovakia

Contacts

CONTACTNovo Nordisk
clinicaltrials@novonordisk.com(+1) 866-867-7178
STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026