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

NCTNCT07587710Other idNN9490-8156Other idU1111-1320-4875Other id2025-521647-20Other id2025

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 1
Enrollment: 35 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Slovakia
Start: 13 May 2026 (estimated)
Primary completion: 1 Dec 2027 (estimated)
Completion: 1 Dec 2027 (estimated)
First posted: 14 May 2026
Last update posted: 14 May 2026
Conditions: Overweight · Obesity

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 1
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
NCT07587710
est. 13 May 2026 to est. 1 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

NNC0487-0111Drug

Arms4

Experimental
Severe hepatic impairment
Participants will receive single dose of NNC0487-0111 subcutaneously.
Experimental
Moderate hepatic impairment
Participants will receive single dose of NNC0487-0111 subcutaneously.
Experimental
Mild hepatic impairment
Participants will receive single dose of NNC0487-0111 subcutaneously.
Experimental
Normal hepatic impairment
Participants will receive single dose of NNC0487-0111 subcutaneously.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Measured as hours\*nanomole per liter (nmol\*h/L)

Secondary outcomes(6)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.