Clinical trial • Phase III • Gastroenterology
Lepodisiran for Hepatic impairment
Phase III trial of Lepodisiran for Hepatic impairment. None/Not specified-controlled. 27 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Hepatic impairment
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 07-04-2025
- First CTIS Authorization Date
- 16-06-2025
Trial design
None/Not specified-controlled Phase III trial across 1 site in Hungary.
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 27
Eligibility
Recruits 27 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent or assent handling provided in source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent or assent handling provided in source.
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 27
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 306
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- CRU Hungary Kft.
- Contact Person Name
- Géza Lakner
- Contact Person Email
- glakner@cruint.com
- Number Of Participants
- 6
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Lepodisiran
Related trials
Other published trials that may interest you.