Safety and Tolerability of Oral Proglumide for NASH
Status:
Active, not recruiting
Trial end date:
2021-09-09
Target enrollment:
Participant gender:
Summary
This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and
efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating
doses in subjects with NASH.
An extended use protocol has been approved for subjects completing this study that show
benefit or are at risk of Liver disease progression to continue on Proglumide at 1200 mg /
day for an additional 3-9 months. Subjects in the extended protocol will have telephone
visits monthly and in the research unit every 3 months for safety lab tests and research
blood for fibrosis analysis.