A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

Launched by AKERO THERAPEUTICS, INC · Sep 2, 2021

Keywords

ClinConnect Summary

The Symmetry trial is studying a medication called efruxifermin (EFX) to see how it affects people with compensated cirrhosis caused by a liver condition known as Nonalcoholic Steatohepatitis (NASH). This study is for adults aged 18 to 75 who have been diagnosed with NASH and have specific health conditions such as Type 2 diabetes or components of metabolic syndrome, which includes issues like obesity or high blood pressure. Participants will be randomly assigned to receive either the medication or a placebo (a treatment that looks the same but has no active ingredients) to compare the effects.

If you are considering joining this trial, you should know that it is currently active but not recruiting new participants. Eligible individuals will have their health monitored closely throughout the study. However, there are certain criteria that may exclude someone from participating, such as significant weight loss recently or having uncontrolled diabetes. This trial aims to gather important information about the safety and effectiveness of efruxifermin, which could help improve treatment options for people living with NASH.

Gender

ALL

Eligibility criteria

• 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