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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04134091 | The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis | PHASE2 | COMPLETED | 56 | — | — | Aug 27, 2019 | Jun 24, 2021 | Dec 14, 2023 | 19 | United States |
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | LPCN 1144 Formulation A |
| Treatment B | EXPERIMENTAL | LPCN 1144 Formulation B |
| Treatment C | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| LPCN 1144 Formulation A | DRUG | Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID). |
| LPCN 1144 Formulation B | DRUG | Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as 225 mg testosterone undecanoate + 238 mg d-alpha tocopherol BID |
| Placebo | DRUG | Oral matching placebo capsule administered as BID |
Inclusion Criteria: 1. Male between 18 and 80 years of age, inclusive. 2. Subject with histologic evidence of NASH upon central read of a liver biopsy. i. A historical biopsy no more than 4 months before Screening may be considered for use with medical monitor approval if the following criteria...