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ARTICLE | Clinical News

Gemphire stops NAFLD pediatric trial of gemcabene after liver fat elevations

August 10, 2018 7:26 PM UTC

Gemphire Therapeutics Inc. (NASDAQ:GEMP) will terminate an open-label Phase IIa trial of gemcabene (CI-1027) to treat pediatric patients with non-alcoholic fatty liver disease (NAFLD) after the first three patients to complete the 12-week trial showed higher levels of liver fat content, which the investigator deemed likely related to gemcabene. All three patients also showed elevated serum alanine transaminase (ALT) levels.

Gemphire terminated the trial at the recommendation of an independent DSMB. All patients in the trial have stopped receiving gemcabene and the DSMB recommended additional follow-up for safety data...