Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04202354 | Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH | PHASE1 | COMPLETED | 50 | — | — | Mar 3, 2020 | Sep 3, 2021 | Oct 3, 2025 | 1 | New Zealand |
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...