The Symmetry study is evaluating an investigational drug, efruxifermin (EFX), to find out if it can reverse liver damage in people with compensated cirrhosis due to NASH.
You may qualify for the Symmetry study if you meet the following criteria:
- 18–75 years of age
- Diagnosed with severe liver scarring (cirrhosis) due to NASH confirmed by a liver biopsy (either within the past year or performed during Screening)
- Diagnosed with type 2 diabetes (past or current) OR diagnosed with 2 of the following: obesity, high cholesterol or triglycerides, high blood pressure, or high blood sugar
- No previous liver transplant
Other criteria will apply. Your medical history and other study requirements will be reviewed with you to determine if you may qualify.
Participation in the Symmetry study may last up to 96 weeks (about 2 years):
- Screening (Up to 8 weeks)
- Receive health assessments to find out if you qualify
- Study Period (96 weeks)
- Be assigned at random to receive EFX or placebo (a substance that looks like EFX but does not contain any active ingredients)
- 2 out of 3 chance of receiving EFX
- 1 out of 3 chance of receiving placebo
- Receive an injection 1 time per week, either in the study clinic or at home (if available)
- Visit the study clinic for health assessments about every 4 weeks (sometimes every 12 weeks)
- The dose of study drug you are receiving may change after 52 weeks of treatment. Your study doctor will share information about this later.
- Follow-up (30 days)
- Visit the study clinic about 30 days after your last injection for final health assessments
All study participants will have their health monitored throughout the study. Some study assessments will include blood tests and heart tests (ECG), and liver tests (liver biopsy and abdominal ultrasounds).
No. All study visits, medical procedures, lab tests, supplies, and the study drug are provided at no cost. Reimbursement for study-related travel expenses may be available.
