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

2025-521647-20-00 Protocol NN9490-8156 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 12 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol NN9490-8156

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 35
Countries 1
Sites 2

hepatic impairment

Key facts

Sponsor
Novo Nordisk A/S
Participant type
Patients, Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Not possible to specify
Trial duration
12 May 2026 → ongoing
Decision date (initial)
2026-04-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-521647-20-00
WHO UTN
U1111-1320-4875

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

hepatic impairment

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation
Novo Nordisk A/S
Address
Novo Alle 1
City
Bagsvaerd
Postcode
2880
Country
Denmark

Scientific contact point

Organisation
Novo Nordisk A/S
Contact name
EU Submission Hub

Public contact point

Organisation
Novo Nordisk A/S
Contact name
EU Submission Hub

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Slovakia Ongoing, recruiting 35 2
Rest of world 0

Investigational sites

Slovakia

2 sites · Ongoing, recruiting
Summit Clinical Research s.r.o.
Zariadenie biomedicinskeho vyskumu, Duklianskych Hrdinov 34, 901 01, Malacky
Summit Clinical Research s.r.o.
Zariadenie biomedicinskeho vyskumu, Nove Mesto, Bardosova 2a, Bratislava

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Slovakia 2026-05-12 2026-05-13

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-12-19 Slovakia Acceptable
2026-04-27
2026-04-27
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-05-14 Slovakia Acceptable
2026-04-27
2026-05-14