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NCT03421431 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
A Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Enanta Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT03421431: Completed Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Enanta Pharmaceuticals.
NCT03421431 is a Phase 2 study of Nonalcoholic Steatohepatitis that has completed, run by Enanta Pharmaceuticals. The registered enrollment target is 134 participants, below the 698-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03421431, a Phase 2 study of Nonalcoholic Steatohepatitis, has completed, sponsored by Enanta Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
Primary Outcome
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG EDP-305 Dose 1
- DRUG EDP-305 Dose 2
Study Locations (20)
California
- Anaheim Clinical Trials - Anaheim
- estudy site - Chula Vista - Chula Vista
- Southern California Research Center - Coronado
- Fresno Clinical Research Center (FCRC) - Fresno
- UCSD Altman Clinical and Translational Research Institute - La Jolla
- Clinical Trials Research - Lincoln
- Cedars-Sinai Medical Center - Los Angeles
- National Research Institute - Los Angeles
- Catalina Research Institute, LLC - Montclair
- Inland Empire Liver Foundation - Rialto
- Southern California Transplantation Institute Research Foundation - San Clemente
- Precision Research Institute - San Diego
Arizona
- Radiant Research Incorporated - Chandler
- Central Arizona Medical Associates - Mesa
- Mayo Clinic Specialty Building - Phoenix
Colorado
- Peak Gastroenterology Associates - Colorado Springs
- Clinical Research Advantage, Inc. / Colorado Springs Family Practice - Colorado Springs
- South Denver Gastroenterology,P.C. - Englewood
Florida
- Avail Clinical Research, LLC - DeLand
- Fleming Island Center for Clinical Research - Fleming Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2019-07-10 |
| Phase | Phase 2 |
What the finished NCT03421431 record still lists
NCT03421431 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 698-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03421431 names 20 study sites across 4 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03421431 about?
NCT03421431 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis". A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
What is the current status of trial NCT03421431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2018-04-25. Estimated completion is 2019-07-10.
What conditions does trial NCT03421431 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT03421431?
The interventions under investigation include: Placebo (DRUG), EDP-305 Dose 1 (DRUG), EDP-305 Dose 2 (DRUG).
Who is sponsoring clinical trial NCT03421431?
This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03421431 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03421431's enrollment target sits among peer trials
134 14th of 30 higher than 17 of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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