At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 87 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
leronlimab 700 mgfrom 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 II, Multi-center, Two-Part, Three-Arm, Dose-Ranging Study of the Safety and Efficacy of Leronlimab (PRO 140) in Adult Patients With Nonalcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating Placebo, leronlimab 700 mg, and 1 other intervention for Nonalcoholic Steatohepatitis (NASH). Completed, enrolled 87 participants across 7 sites.
Detailed Summary
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis (NASH)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartDec 2020
Primary CompletionDec 2021
TodayJul 2026
First PostedAug 20, 2020
Enrollment StartDec 1, 2020
Primary CompletionDec 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.9 years ago
Interventions
Placebodrug
Placebo will be administered subcutaneously every week for 13 weeks.
leronlimab 700 mgdrug
700 mg leronlimab will be administered subcutaneously every week for 13 weeks.
leronlimab 350 mgdrug
350 mg leronlimab will be administered subcutaneously every week for 13 weeks.