Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS-GCCRRx · 1 trial · 1 indication
Change from Baseline to Week 7
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| ISIS-GCCRRx | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ISIS-GCCRRx | DRUG | 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin |
| Placebo | DRUG | 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin |
Inclusion Criteria: * Male or female, age 18 to 75 * BMI greater than or equal to 25 * HbA1c greater than or equal to 7.5% and less than or equal to 10.5% * Type 2 Diabetes Mellitus and on stable dose of oral metformin * Agree to conduct home-based (fasted) blood glucose testing as directed Exclus...
ISIS-GCCRRx is an investigational drug being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and efficacy in patients with this condition.
ISIS-GCCRRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.
ISIS-GCCRRx is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The drug is being evaluated for its safety and efficacy in patients with Type 2 Diabetes Mellitus.
ISIS-GCCRRx has one completed Phase 2 clinical trial registered as NCT01968265, titled "Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes." This randomized, double-blind, placebo-controlled trial enrolled 38 participants and was conducted in Canada, Romania, and South Africa.
No, ISIS-GCCRRx is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has not completed the clinical trial process required for regulatory approval and remains under investigation.