Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company, said Wednesday it is enrolling patients into an open label extension to the ongoing LPCN 1144 Phase 2 LiFT study, based on investigator and patient interest in continuing treatment.
The LiFT (Liver Fat intervention with oral Testosterone) clinical study is a paired-biopsy study that is investigating LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis or NASH subjects.
Lipocine noted that in the initial, double-blind part of the LiFT study, patients were randomized to receive one of two treatments of LPCN 1144 or placebo over 36 weeks.
Patients who complete this portion can now opt to enter the 36-week open label extension study, which is designed to evaluate the long-term safety and tolerability of LPCN 1144 treatment. There is no placebo arm in the open label extension study, and all patients will be treated with LPCN 1144.
“This extension to our ongoing LiFT clinical study will allow us to collect additional data on LPCN 1144 for up to a total of 72 weeks of therapy. Patients who may have received placebo during the initial, randomized part of the trial now have the opportunity to receive active drug,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.
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