Clinical trial • Phase II • Gastroenterology
lanifibranor for Non-alcoholic steatohepatitis | NASH
Phase II trial of lanifibranor for Non-alcoholic steatohepatitis | NASH. Randomised, open-label. 30 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Non-alcoholic steatohepatitis | NASH
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-11-2025
- First CTIS Authorization Date
- 04-02-2026
Trial design
Randomised, open-label Phase II trial across 1 site in France.
- Randomised
- Yes
- Open Label
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected (isVulnerablePopulationSelected = true). No details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
France
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Biotrial
- Department Name
- Unité Clinique
- Contact Person Name
- Hakim Charfi
- Contact Person Email
- Hakim.Charfi@biotrial.com
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Inventiva
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Lanifibranor
- Active Substance
- lanifibranor
- Modality
- Small molecule
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