NCT04202354

Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	ARO-HSD Injection	single or multiple doses of ARO-HSD by subcutaneous (sc) injections
DRUG	sterile normal saline (0.9% NaCl)	calculated volume to match active treatment, by sc injection

Timeline

• Start date: 2020-03-03
• Primary completion: 2021-09-03
• Completion: 2021-09-03
• First posted: 2019-12-17
• Last updated: 2025-10-03
• Results posted: 2025-10-03

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study