At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
CRV431 75mg +3 moredrug
Likely dose
CRV431 75mgfrom 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.
AMBITION: A Phase 2A, Multiple-Center, Single-Blind, Placebo-Controlled Study To Evaluate The Safety and Tolerability of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
In Brief
A Phase 2 clinical trial evaluating CRV431 75mg, Placebo (1 softgel), and 2 other interventions for NASH - Nonalcoholic Steatohepatitis and 2 related conditions. Completed, enrolled 47 participants across 10 sites in 2 countries.
Detailed Summary
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJul 2020
Primary CompletionJun 2021
Study CompletionOct 2021
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartJun 23, 2020
Primary CompletionJun 29, 2021
Study CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.9 years ago
Interventions
CRV431 75mgdrug
1 x 75mg softgel capsule
Placebo (1 softgel)drug
1 x placebo softgel capsule
CRV431 225mgdrug
3 x 75mg softgel capsule
Placebo (3 softgels)drug
3 x placebo softgel capsule