Clinical trial • Phase III • Other
NNC0487-0111 for Hepatic impairment
Phase III trial of NNC0487-0111 for Hepatic impairment. 35 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Hepatic impairment
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 19-12-2025
- First CTIS Authorization Date
- 27-04-2026
Trial design
Phase III trial across 2 sites in Slovakia.
- Target Sample Size
- 35
Eligibility
Recruits 35 Vulnerable population not selected; consent/assent handling not specified..
- Vulnerable Population
- Vulnerable population not selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 19
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 35
Slovakia
- Earliest CTIS Part Ii Submission Date
- 26-03-2026
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 35
Sites
- Site Name
- Summit Clinical Research s.r.o.
- Department Name
- Zariadenie biomedicinskeho vyskumu
- Contact Person Name
- Viera Kupcova
- Contact Person Email
- viera.kupcova@summit-cr.eu
- Site Name
- Summit Clinical Research s.r.o.
- Department Name
- Zariadenie biomedicinskeho vyskumu
- Contact Person Name
- Edita Kadlubiakova
- Contact Person Email
- edita.kadlubiakova@summit-cr.eu
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- NNC0487-0111
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