Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being developed for the treatment of non-alcoholic steatohepatitis (NASH), a condition characterized by fat accumulation and inflammation in the liver. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ARO-HSD is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
ARO-HSD is in Phase 1 clinical development. A Phase 1 trial has been completed, which involved healthy volunteers and patients with non-alcoholic steatohepatitis (NASH) or suspected NASH. The drug remains investigational and is not yet approved for any use.
ARO-HSD has one completed Phase 1 clinical trial, identified as NCT04202354. This study enrolled 50 participants in New Zealand and evaluated the drug in healthy volunteers and patients with non-alcoholic steatohepatitis (NASH) or suspected NASH. The trial was randomized, double-blind, and placebo-controlled.
No alternative names for ARO-HSD have been disclosed. The drug is identified solely by its code name ARO-HSD in clinical trial registries and by its developer, Arrowhead Pharmaceuticals.