Overview

Gemcabene for the Treatment of Pediatric NAFLD

Status:
Terminated

Trial end date:
2019-08-27

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Emory University

Collaborators:

Gemphire Therapeutics
Gemphire Therapeutics, Inc.

Treatments:

Calcium