Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARO-HSD Injection
ARO-HSD · 1 trial · 1 indication
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ARO-HSD 25 mg | EXPERIMENTAL | Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| Cohort 2: ARO-HSD 50 mg | EXPERIMENTAL | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| Cohort 3: ARO-HSD 100 mg | EXPERIMENTAL | Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| Cohort 4: ARO-HSD 200 mg | EXPERIMENTAL | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| Cohort 1b: ARO-HSD 25 mg | EXPERIMENTAL | Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. |
| Cohort 3b: ARO-HSD 100 mg | EXPERIMENTAL | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. |
| Cohort 4b: ARO-HSD 200 mg | EXPERIMENTAL | Participants with suspected NASH receive open-label ARO-HSD 200 mg on Days 1 and 29. |
| Name | Type | Description |
|---|---|---|
| ARO-HSD Injection | DRUG | 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 |
Inclusion Criteria: * Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * Willing to provide written informed consent and to comply with study requirements * On a stable diet for at least 4 weeks with no plans to s...
ARO-HSD is an investigational therapy being developed for non-alcoholic steatohepatitis, or NASH, a metabolic liver condition. It has been studied in a Phase 1 trial that enrolled healthy volunteers along with patients who had NASH or suspected NASH. It is not an approved treatment.
ARO-HSD is being developed by Arrowhead Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ARWR. The company sponsored the Phase 1 study of ARO-HSD in healthy volunteers and patients with NASH or suspected NASH.
ARO-HSD is in Phase 1 clinical development. Its single Phase 1 trial, NCT04202354, has been completed, and no trials of ARO-HSD are currently active. The drug remains investigational and has not been approved for any indication.
ARO-HSD has been evaluated in one Phase 1 trial, NCT04202354, titled Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH. That trial was completed and enrolled 50 participants in New Zealand. It was randomized, double blind, and placebo controlled.
Yes. ARO-HSD Injection is another name for ARO-HSD, the investigational NASH therapy developed by Arrowhead Pharmaceuticals. Both names refer to the same asset, so searches for either term point to the same Phase 1 program.
The Phase 1 trial of ARO-HSD, NCT04202354, enrolled 50 participants. It included healthy volunteers as well as patients with NASH or suspected NASH, and participants were at least 19 years old. The study was randomized, double blind, and placebo controlled.