Clinical Trials List
2024-01-12 - 2026-09-11
Phase III
Not yet recruiting4
Recruiting2
Study ended1
ICD-10K74.4
Secondary biliary cirrhosis
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-10K76.0
Fatty (change of) liver, not elsewhere classified
ICD-10K76.89
Other specified diseases of liver
ICD-10R16.2
Hepatomegaly with splenomegaly, not elsewhere classified
ICD-9571.8
Other chronic nonalcoholic liver disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
Pharmaceutical Research Associates Taiwan Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/12/04
Investigators and Locations
Co-Principal Investigator
- 洪俊銘 無
- Chun-Jen Liu 無
- Tiffany Ting-Fang Shih 無
- 楊宏志 無
- Shih-Jer Hsu 無
- Chen-Hua Liu 無
- 吳志宏 無
- 曾岱宗 無
- 蘇東弘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 邱彥程 無
- Chiu Hung Chiu 無
- 簡世杰 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• To assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/NAFLD
Inclution Criteria
• Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
• Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes
• Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD
Exclusion Criteria
• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
• Type 1 or unstable Type 2 diabetes
A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.
Other inclusion and exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
700 participants
