Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS 325568 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 50 mg ISIS 325568 vs Placebo, s.c. injection |
| B | EXPERIMENTAL | 100 mg ISIS 325568 vs Placebo , s.c. injection |
| C | EXPERIMENTAL | 200 mg ISIS 325568 vs Placebo , s.c. injection |
| D | EXPERIMENTAL | 400 mg ISIS 325568 vs Placebo, s.c. injection |
| AA | EXPERIMENTAL | 50 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| BB | EXPERIMENTAL | 100 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| CC | EXPERIMENTAL | 200 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| DD | EXPERIMENTAL | 400 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 325568 | DRUG | 4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
Inclusion Criteria: 1. Age 18 to 65 years 2. Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bea...
ISIS 325568 is an investigational drug being developed for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being studied in the metabolic therapeutic area. As of the available data, it is in Phase 1 clinical development and is not yet approved for any use.
ISIS 325568 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IONS. The company is conducting clinical research on this investigational drug for Type 2 Diabetes Mellitus.
ISIS 325568 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical research for Type 2 Diabetes Mellitus.
ISIS 325568 has been studied in one clinical trial, identified as NCT00519727, titled "Safety Study of ISIS 325568 in Healthy Volunteers." This Phase 1 trial was completed and enrolled 60 participants in the Netherlands. The trial was randomized, double-blind, and controlled.
ISIS 325568 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The available data shows one completed Phase 1 trial, but no approval status has been established.