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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05519475 | A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition | PHASE2 | RECRUITING | 120 | — | — | Feb 9, 2023 | Dec 7, 2028 | May 19, 2026 | 71 | United States, Japan +2 |
Change in the continuous qFibrosis score measured by second harmonic generation/two-photon excitation microscopy
| Arm | Type | Description |
|---|---|---|
| ALN-HSD | EXPERIMENTAL | Randomized 1:1 |
| Placebo | PLACEBO_COMPARATOR | Randomized 1:1 |
| Name | Type | Description |
|---|---|---|
| ALN-HSD | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5....