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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04874350 | A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia | PHASE2 | COMPLETED | 30 | — | — | Nov 30, 2021 | Dec 18, 2023 | Mar 15, 2024 | 10 | United States |
| Arm | Type | Description |
|---|---|---|
| LPCN 1148 | EXPERIMENTAL | Oral LPCN 1148 capsules, administered as BID. |
| Placebo | PLACEBO_COMPARATOR | Oral matching placebo capsules, administered as BID. |
| Name | Type | Description |
|---|---|---|
| LPCN 1148 | DRUG | LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics. |
| Placebo | DRUG | Oral matching placebo capsule |
Inclusion Criteria: 1. Male ≥ 18 years old 2. Currently listed, on the liver transplant waitlist for cirrhosis secondary to Hepatitis B or C infection, Alcoholic Liver Disease (ALD), Non-Alcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), or Primary Sclerosing Cholangitis (PSC) 3. ...