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LPCN 1148 · 1 trial · 2 indications
| 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. ...
LPCN 1148 is an investigational oral small molecule being developed for the treatment of liver cirrhosis, specifically in male patients with cirrhosis of the liver and sarcopenia, which is the loss of skeletal muscle mass. It is not approved for any indication and remains in clinical development.
LPCN 1148 targets the androgen receptor, a receptor class protein. By acting on the androgen receptor, the small molecule is designed to address the metabolic and muscle-wasting complications seen in men with cirrhosis. It is an oral therapy being studied in this patient population.
LPCN 1148 is being developed by Lipocine Inc., a biopharmaceutical company that trades under the ticker symbol LPCN. Lipocine is the sponsor responsible for advancing the asset through clinical development for liver cirrhosis with sarcopenia in male patients.
LPCN 1148 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The completed Phase 2 study evaluated the drug in male subjects with cirrhosis of the liver and sarcopenia.
LPCN 1148 has been studied in one completed Phase 2 trial, NCT04874350, titled a study to assess the efficacy, safety, and tolerability of oral LPCN 1148 in male subjects with cirrhosis of the liver and sarcopenia. The trial enrolled 30 participants in the United States and was randomized, double-blind, and placebo-controlled.