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On August 25, 2021, Lipocine announced that its investigational therapy LPCN 1144 has obtained positive results in the Phase 2 proof-of-concept clinical trial LiFT for the treatment of male patients with non-alcoholic steatohepatitis (NASH)
This randomized, double-blind, placebo-controlled LiFT trial recruited male NASH patients with F1-F3 stage fibrosis confirmed by biopsy and NAFLD activity score ≥4, and their gonadal function was hypothyroid or normal
When the trial reached the primary endpoint, that is, at week 12, as assessed by MRI-PDFF, LPCN 1144 treatment resulted in a 46.
In terms of secondary endpoints, after 36 weeks of treatment, according to the histological NASH CRN score of the liver, the two LPCN 1144 treatment groups reached the criteria for significantly eliminating NASH symptoms and not causing liver fibrosis to worsen
Picture source: reference [1]
In terms of safety, LPCN 1144 was well tolerated during the 36-week treatment period, and the overall safety profile was comparable to placebo
(The original text has been deleted)
Reference materials:
[1] Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study.
