Study Results

• What We Learned:

  This study found that the drug liprotamase was not as effective as the approved drug pancrelipase (Pancreaze®). Liprotamase was generally well-tolerated; however, more participants on liprotamase discontinued the study early than those taking pancrelipase (28% versus 8%).

• Primary Findings:

  Effectiveness:

  This study was conducted between September 2015 and January 2017. The study enrolled 129 participants with 65 participants receiving liprotamase and 64 receiving pancrelipase. There was a higher number of discontinuations in the liprotamase group (N=18, 28%) compared to the pancrelipase group (N=5, 8%).

   

  The primary objective of the study was to determine if liprotamase was at least as effective as pancrelipase. This study did not meet its primary goal as liprotamase was not as effective as pancrelipase in helping the CF participants absorb fat from their food.  

   

  Additional evaluations showed that participants receiving liprotamase reported more abdominal pain, bloating and oily stools than participants receiving pancrelipase. 

  Safety:

  Liprotamase was generally well-tolerated with a similar adverse event profile as pancrelipase. However, as noted above, there were significantly more discontinuations in the liprotamase group, with the most common reason being withdrawal of consent (N=9, 14%). There were three discontinuations in the liprotamase group due to an adverse event (5%).

• Citation:

  Clinical Drug Investigation 2018;DOI 10.4172/ Clinical-Investigation.1000141

For current information about the overall development status of this drug, please check the Drug Development Pipeline.