Clinical trial • Phase III • Endocrinology|Gastroenterology

Silymarin for Metabolic dysfunction-associated steatotic liver disease (MASLD)|Chronic liver disease

Phase III trial of Silymarin for Metabolic dysfunction-associated steatotic liver disease (MASLD)|Chronic liver disease. 48 participants.

Overview

Trial Therapeutic Area
Endocrinology|Gastroenterology
Trial Disease
Metabolic dysfunction-associated steatotic liver disease (MASLD)|Chronic liver disease
Trial Stage
Phase III
Drug Modality
Other

Key dates

Initial CTIS Submission Date
10-10-2025
First CTIS Authorization Date
17-11-2025

Trial design

Phase III trial across 1 site in Germany.

Target Sample Size
48
Trial Duration For Participant
303

Eligibility

Recruits 48 No vulnerable population selected (isVulnerablePopulationSelected:false). Consent/assent handling not described in available data..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected:false). Consent/assent handling not described in available data.

Recruitment

Planned Sample Size
48
Recruitment Window Months
9

Geography

Total Number Of Sites
1
Total Number Of Participants
48

Germany

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
129
Number Of Sites
1
Number Of Participants
48

Sites

Site Name
CRS Clinical Research Services Mannheim GmbH
Department Name
Clinic
Contact Person Name
Marina Streckebein

Sponsor

Primary sponsor

Full Name
Bionorica SE
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
CRS Clinical Research Services Mannheim GmbH
Responsibilities
Local trial site / clinical research services (site listed in trialSites)

Investigational products

Investigational Product Name
Acetonic milk thistle extract (standardized to silymarin)
Active Substance
Silymarin
Modality
Other

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