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LPCN 1144 Formulation A · 1 trial · 1 indication
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...
LPCN 1144 Formulation A is an investigational oral small molecule being studied for the treatment of nonalcoholic steatohepatitis (NASH), a form of fatty liver disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
LPCN 1144 Formulation A is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with NASH.
LPCN 1144 Formulation A is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and has not received FDA approval. Further studies would be needed to establish its safety and efficacy for regulatory review.
LPCN 1144 Formulation A was evaluated in a completed Phase 2 trial with the identifier NCT04134091. This randomized, double-blind, placebo-controlled study enrolled 56 male participants aged 18 years and older with nonalcoholic steatohepatitis (NASH) at sites in the United States.
No, LPCN 1144 Formulation A is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for nonalcoholic steatohepatitis (NASH). The drug is still in clinical development and has not been authorized for commercial use.