Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05039450 | A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry) | PHASE2 | ACTIVE NOT_RECRUITING | 182 | — | — | Jul 30, 2021 | May 1, 2025 | Apr 9, 2025 | 49 | United States, Mexico +1 |
| NCT03976401 | A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 110 | — | — | May 28, 2019 | Jan 10, 2022 | Aug 4, 2022 | 27 | United States, Puerto Rico |
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36.
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
| Arm | Type | Description |
|---|---|---|
| EFX 28 mg (Main Study) | EXPERIMENTAL | - |
| EFX 50 mg (Main Study) | EXPERIMENTAL | - |
| Placebo (Main Study) | PLACEBO_COMPARATOR | - |
| EFX 50 mg (Cohort D) | EXPERIMENTAL | - |
| Placebo (Cohort D) | PLACEBO_COMPARATOR | - |
| EFX Dose 1 | EXPERIMENTAL | Main Study |
| EFX Dose 2 | EXPERIMENTAL | Main Study |
| EFX Dose 3 | EXPERIMENTAL | Main Study |
| Placebo | PLACEBO_COMPARATOR | Main Study |
| EFX Dose (Cohort C) | EXPERIMENTAL | - |
| Placebo (Cohort C) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EFX | DRUG | Investigational drug, Efruxifermin |
| Placebo | DRUG | Placebo |
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...