Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALG-055009 · 4 trials · 7 indications
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
AUC0-24, of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
AUClast of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
AUCinf of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
Tmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
Cmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
C24 of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
C0 (predose) of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
t½ of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Pharmacokinetic parameters of atorvastatin and applicable metabolites
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
| 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 |
| Sequence A | EXPERIMENTAL | Single dose PO administration of 0.7 mg ALG-055009 (Formulation 1; Day 1), then a washout period of at least 7 days, followed by single dose PO administration of 0.7 mg ALG-055009 (Formulation 2; Day 8) |
| Sequence B | EXPERIMENTAL | Single dose PO administration of 0.7 mg ALG-055009 (Formulation 2; Day 1), then a washout period of at least 7 days, followed by single dose PO administration of 0.7 mg ALG-055009 (Formulation 1; Day 8) |
| Atorvastatin with ALG-055009 | EXPERIMENTAL | Single dose PO administration of 40 mg atorvastatin (Day 1), then a washout period of at least 2 days, followed by PO QD administration of 0.9 mg ALG-055009 for 14 days (Days 3-16) and single dose PO administration of 40 mg atorvastatin (Day 15). |
| Rosuvastatin with ALG-055009 (optional) | EXPERIMENTAL | Single dose PO administration of 10 mg rosuvastatin (Day 1), then a washout period of at least 4 days, followed by PO QD administration of 0.9 mg ALG-055009 for 11 days (Days 5-15) and single dose PO administration of 10 mg rosuvastatin (Day 11). |
| ALG-055009 | EXPERIMENTAL | Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
| Name | Type | Description |
|---|---|---|
| ALG-055009 | DRUG | Softgel Capsule |
| Placebo | DRUG | Softgel Capsule |
| Atorvastatin | DRUG | 40 mg |
| Rosuvastatin | DRUG | 10 mg |
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...