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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06342947 | ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) | PHASE2 | COMPLETED | 102 | — | — | Apr 1, 2024 | Sep 9, 2024 | Feb 17, 2025 | 40 | United States |
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
| Arm | Type | Description |
|---|---|---|
| ALG-055009 softgel capsule 0.3mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.3mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.5mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.5mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.7mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.7mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.9mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.9mg Daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo softgel capsule Daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| ALG-055009 | DRUG | Softgel Capsule |
| Placebo | DRUG | Softgel Capsule |
Key Inclusion Criteria: * Male or female, 18 to 75 years of age * Body mass index (BMI) ≥ 25 kg/m2 * Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following: * Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least...