At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 134 enrolled
Drug / intervention
EDP-305 Dose 1 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating EDP-305 Dose 1, EDP-305 Dose 2, and 1 other intervention for Non-Alcoholic Steatohepatitis. Completed, enrolled 134 participants across 82 sites in 6 countries.
Detailed Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Alcoholic Steatohepatitis
CountriesCanada, France, New Zealand, Puerto Rico, United Kingdom, United States
CollaboratorsICON Clinical Research, Triangle Biostatistics, LLC
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartApr 2018
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedFeb 5, 2018
Enrollment StartApr 25, 2018
Primary CompletionJun 14, 2019
Study CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.4 years ago
Interventions
EDP-305 Dose 1drug
Two tablets daily for 12 weeks
EDP-305 Dose 2drug
Two tablets daily for 12 weeks
Placebodrug
Two tablets daily for 12 weeks