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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