Gemcabene for the Treatment of Pediatric NAFLD

Summary

This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcabene once a day for 12 weeks will reduce alanine aminotransferase (ALT), hepatic steatosis, dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.

Timeline

Start

2018-03-29

Primary completion

2019-08-27

Completion

2019-08-27

Outcome

Outcome not reported

Stopped: “Terminated due to lack of efficacy and safety concerns.”

Drugs

Indications