Study: Results from an OLE Trial for NASH

LPCN 1144 for nonalcoholic steatohepatitis (NASH) has already demonstrated positive results in the LiFT trial, and it is now showing more exciting results in its open-label extension (OLE) trial. Want to read more about them? You can check out the source article from Central Charts.

About NASH

First up, let’s get a better understanding of what NASH is. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. This leads to inflammation and scarring which may go on to impact liver function. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen.

Symptoms of NASH include:

  • Jaundice
  • Itching
  • Weakness
  • Nausea
  • Vomiting
  • Fatigue
  • Swelling in the legs and abdomen
  • Mental confusion
  • Loss of appetite
  • Abdominal pain
  • Spider-like blood vessels

About the OLE Trial

16 patients from the LiFT trial joined nine others to make a total of 25 participants in the OLE trial. These 16 spent another 36 weeks on LPCN 1144, which added up to a total of 72 weeks on the drug. Of the participants, 23 finished. One did not do so due to a non-drug related treatment emergent adverse event. Additionally, six patients opted to have a liver biopsy at the end of the OLE trial.

Researchers working on this trial evaluated all patients in order to investigate LPCN 1144’s safety, tolerability, and impact on overall health at six week intervals. The following results were observed:

  • When compared to the prior LiFT study, safety and tolerability profiles remained similar
    • Severity and frequency of non-drug related treatment emergent adverse events also remained similar
    • Change in weight from baseline remained similar and was minimal overall
    • Researchers did not note any clinically meaningful changes in lipids
  • There was a reduction in liver injury markers from baseline
    • Markers include gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)
  • Researchers observed improvements in liver histology
    • Biopsies were analyzed using the Clinical Research Network (CRN) scoring
    • Efficacy was proven with extended treatment

At the end of the day, these trial results support further development of LPCN 1144 for NASH patients. Hopefully, it will become a viable treatment option for patients.

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