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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06528314 | A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH | PHASE3 | RECRUITING | 2,150 | — | — | Sep 4, 2024 | Mar 1, 2030 | Jun 8, 2026 | 322 | United States, Argentina +17 |
| NCT04767529 | A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 128 | — | — | Feb 16, 2021 | May 2, 2024 | Jun 18, 2025 | 55 | United States, Puerto Rico |
Measured by composite of protocol-specified clinical events
Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Proportions of subjects in EFX vs placebo groups with improvement in liver fibrosis, defined as ≥ 1 stage NASH Clinical Research Network \[CRN\] fibrosis score (score ranges from 0 to 4, increasing with fibrosis severity), and no worsening of steatohepatitis (no increase in NASH Activity Score \[NAS\], which ranges from 0 to 8 and is the sum of scores of steatosis, lobular inflammation, and hepatocyte ballooning), at Week 24
| Arm | Type | Description |
|---|---|---|
| EFX 50 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Efruxifermin 28 mg | EXPERIMENTAL | double-blind, once-weekly subcutaneous injection |
| Efruxifermin 50 mg | PLACEBO_COMPARATOR | double-blind, once-weekly subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Efruxifermin | DRUG | Administered by subcutaneous injection |
| Placebo | DRUG | Administered by subcutaneous injection |
Inclusion Criteria: * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities * Cohort 2: Biopsy proven or non-invasively diagnosed compensated ci...