A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepa… (NCT06161571) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Evaluating 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)
United States700 participantsStarted 2023-11-10
Plain-language summary
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
Main Study Only:
* 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
Open-Label Rollover
* Prior participation in a previous Akero Phase 2 study
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.
What they're measuring
1
Extent of exposure
Timeframe: 52 Weeks
2
Number of participants with adverse events
Timeframe: 52 Weeks
3
Number of participants with adverse events by severity
Timeframe: 52 Weeks
4
Number of participants with clinically significant changes in clinical assessments