Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GK1-399 (formerly TTP399)
GK1-399 · 1 trial · 1 indication
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| GK1-399, low dose | EXPERIMENTAL | - |
| GK1-399, high dose, once per day | EXPERIMENTAL | - |
| GK1-399, high dose, twice per day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GK1-399 (formerly TTP399) | DRUG | Treatment A: GK1-399 200 mg. Oral administration, twice per day. |
| Placebo | DRUG | Dose-matched placebo. Oral administration. |
Inclusion Criteria: * Be male or female, aged 18 through 75 years at screening. * Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) * On a stable dose of background medication for the treatment of diabetes * Body Mass Index (BMI) between 20-40 kg/m2 (inclusive) Exclusion Criteria: * Subjects wi...
GK1-399 is an investigational small molecule developed by vTv Therapeutics Inc. (ticker VTVT) for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. It is not approved for commercial use.
GK1-399 is being developed for the treatment of Type 2 Diabetes Mellitus. It is an investigational therapy and has not been approved for any indication. Its clinical evaluation has focused on patients with Type 2 Diabetes Mellitus, as reflected in the completed Phase 1 trial.
GK1-399 is developed by vTv Therapeutics Inc., a biopharmaceutical company whose ticker symbol is VTVT. vTv Therapeutics is responsible for the clinical development of GK1-399 for Type 2 Diabetes Mellitus.
GK1-399 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any regulatory agency for Type 2 Diabetes Mellitus.
GK1-399 has been evaluated in one completed Phase 1 clinical trial, NCT01474083, titled "A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes." The trial enrolled 248 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, GK1-399 is also known as TTP399. GK1-399 (formerly TTP399) is the same investigational small molecule developed by vTv Therapeutics Inc. for Type 2 Diabetes Mellitus. The alternative name TTP399 refers to the same drug candidate.