Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its effects on pharmacokinetics, pharmacodynamics, safety, and tolerability in patients with this condition.
GK1-399 is being developed by vTv Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VTVT. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug candidate for Type 2 Diabetes Mellitus.
GK1-399 is currently in Phase 1 clinical development. A Phase 1 clinical trial has been completed, which evaluated the drug's pharmacokinetics, pharmacodynamics, safety, and tolerability in patients with Type 2 Diabetes Mellitus. The drug remains investigational and has not received regulatory approval.
GK1-399 has one completed clinical trial registered under NCT01474083, titled "A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes." This Phase 1 study enrolled 248 participants in the United States and was randomized, double-blind, and placebo-controlled.
GK1-399 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The completed Phase 1 trial assessed safety, tolerability, pharmacokinetics, and pharmacodynamics, but the drug has not yet progressed through the later stages of clinical development required for regulatory approval.