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Cholecystokinin Receptor Antagonist

Proglumide for Non-alcoholic Fatty Liver Disease (STOPNASH Trial)

Phase 1
Waitlist Available
Led By Jill P Smith, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks per dose
Awards & highlights

STOPNASH Trial 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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

STOPNASH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks per dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks per dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended Phase 2 dose
safety and toxicity
Secondary outcome measures
Liver transaminases
Other outcome measures
NASH score by Fibroscan

STOPNASH Trial Design

1Treatment groups
Experimental Treatment
Group I: ProglumideExperimental Treatment1 Intervention
Open labelled proglumide treated
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proglumide
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,484 Total Patients Enrolled
Jill P Smith, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability of Oral Proglumide for NASH
2019. "Safety and Tolerability of Oral Proglumide for NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04152473.
~3 spots leftby Apr 2025
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