Clinical trial • Phase III • Gastroenterology
LY3537031 for Liver impairment (hepatic insufficiency) | Healthy volunteers
Phase III trial of LY3537031 for Liver impairment (hepatic insufficiency) | Healthy volunteers. None/Not specified-controlled. 24 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Liver impairment (hepatic insufficiency) | Healthy volunteers
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 17-10-2025
Trial design
None/Not specified-controlled Phase III trial across 2 sites in Slovakia, Hungary.
- Comparator
- None/Not specified
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population selected; no details on consent/assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent/assent handling available in the record.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 9
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 26
Slovakia
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 151
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Summit Clinical Research s.r.o.
- Department Name
- Department of Internal Medicine and Clinical Pharmacology
- Contact Person Name
- Viera Kupčová
- Contact Person Email
- kupcova@vnet.sk
- Number Of Participants
- 12
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-09-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 202
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- CRU Hungary Kft.
- Contact Person Name
- Geza Lakner
- Contact Person Email
- glakner@cruint.com
- Number Of Participants
- 14
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- LY3537031
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