At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
ARO-HSD Injection +1 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 1/2a Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-HSD in Normal Healthy Volunteers as Well as in Patients With NASH or Suspected NASH
In Brief
A Phase 2 clinical trial evaluating ARO-HSD Injection and sterile normal saline (0.9% NaCl) for Non-alcoholic Steatohepatitis. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Steatohepatitis
CountriesNew Zealand
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartMar 2020
Primary CompletionSep 2021
TodayJul 2026
First PostedDec 17, 2019
Enrollment StartMar 3, 2020
Primary CompletionSep 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.5 years ago
Interventions
ARO-HSD Injectiondrug
single or multiple doses of ARO-HSD by subcutaneous (sc) injections
sterile normal saline (0.9% NaCl)drug
calculated volume to match active treatment, by sc injection