A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatiti… (NCT05039450) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
United States182 participantsStarted 2021-07-30
Plain-language summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
* Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
* Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
* Cohort D Only: Diagnosis of type 2 diabetes
* Cohort D Only: Use of GLP-1R agonist for at least 90 days
* Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3
Exclusion Criteria:
* Main Study Only: Weight loss \> 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
* Type 1 diabetes or uncontrolled Type 2 diabetes
* Cohort D Only: Weight loss \> 5% in the 90 days prior to screening
* Cohort D Only: Presence of cirrhosis on liver biopsy
Other inclusion and exclusion criteria may apply
What they're measuring
1
Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system