Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS 388626 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 50 mg ISIS 388626 vs Placebo, s.c. injection |
| B | EXPERIMENTAL | 100 mg ISIS 388626 vs Placebo, s.c. injection |
| C | EXPERIMENTAL | 200 mg ISIS 388626 vs Placebo, s.c. injection |
| D | EXPERIMENTAL | 400 mg ISIS 388626 vs Placebo, s.c. injection |
| AA | EXPERIMENTAL | 50 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo |
| BB | EXPERIMENTAL | 100 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo |
| AAA | EXPERIMENTAL | 50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| BBB | EXPERIMENTAL | 100 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| CCC | EXPERIMENTAL | 200 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| FFF | EXPERIMENTAL | 50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 388626 | DRUG | 4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg Placebo: 0.9% sterile saline |
Inclusion Criteria: * Age 18 to 65 years * Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation) * Give written informed consent to participate in the study and availability for all study requirements * Fasting plasma glu...
ISIS 388626 is an investigational drug being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and activity in clinical trials.
ISIS 388626 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research on this investigational drug for Type 2 Diabetes Mellitus.
ISIS 388626 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety, tolerability, and activity in patients with Type 2 Diabetes Mellitus.
ISIS 388626 has been studied in one completed Phase 1 clinical trial, identified as NCT00836225. This trial was a safety, tolerability, and activity study of multiple doses of ISIS-SGLT2Rx in healthy volunteers. The study enrolled 103 participants and was conducted in the Netherlands.
Yes, ISIS 388626 is also known as ISIS-SGLT2Rx. This alternative name was used in the clinical trial NCT00836225, which studied the drug in healthy volunteers for conditions related to Type 2 Diabetes Mellitus.