Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS 703802 · 1 trial · 4 indications
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.
| Arm | Type | Description |
|---|---|---|
| Pooled Placebo | PLACEBO_COMPARATOR | Participants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC). |
| Cohort B: ISIS 703802, 40 mg Q4W | EXPERIMENTAL | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. |
| Cohort C: ISIS 703802, 80 mg Q4W | EXPERIMENTAL | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. |
| Cohort A: ISIS 703802, 20 mg QW | EXPERIMENTAL | Participants received ISIS 703802, 20 mg once every week for 26 doses. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo (Matched with ISIS 703802) |
| ISIS 703802 40 mg | DRUG | ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses. |
| ISIS 703802 80 mg | DRUG | ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses. |
| ISIS 703802 20 mg | DRUG | ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses. |
Key Inclusion Criteria: * Plasma triglycerides (TG) at Screening greater than (\>)150 milligrams per deciliter (mg/dL) and at qualification of \>150 mg/dL. * Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (\>...
ISIS 703802 is an investigational small molecule being developed for nonalcoholic fatty liver disease (NAFLD). It is also being studied in patients with hypertriglyceridemia and type 2 diabetes mellitus, conditions that often accompany NAFLD. The drug is in Phase 2 clinical development.
ISIS 703802 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IONS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metabolic conditions including NAFLD.
ISIS 703802 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities. The completed study enrolled 105 participants.
ISIS 703802 has been studied in one completed Phase 2 trial with the identifier NCT03371355. The trial enrolled 105 participants with hypertriglyceridemia, type 2 diabetes mellitus, and nonalcoholic fatty liver disease. It was a randomized, double-blind, placebo-controlled study conducted in the United States and Canada.
ISIS 703802 is the drug name used in clinical trials, and no alternative names have been reported. It is an investigational small molecule developed by Ionis Pharmaceuticals for the treatment of nonalcoholic fatty liver disease and related metabolic conditions.