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TTP399 · 2 trials · 2 indications
To evaluate the change in glycosylated hemoglobin (HbA1C) in Part 1 and Part 2 participants following multiple-day dosing (at 12 weeks) in subjects with T1MD. Sentinel participants were not evaluated for a change in HbA1C.
AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours.
| Arm | Type | Description |
|---|---|---|
| TTP399 400 mg | EXPERIMENTAL | TTP399 once daily |
| TTP399 800 mg | EXPERIMENTAL | TTP399 once daily |
| Sitagliptin 100 mg | ACTIVE_COMPARATOR | Sitagliptin once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily |
| Name | Type | Description |
|---|---|---|
| TTP399 400 mg | DRUG | once daily |
| TTP399 800 mg | DRUG | once daily |
| Sitagliptin 100 mg | DRUG | once daily |
| Placebo | DRUG | once daily |
| TTP399 | DRUG | Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days |
| Placebo Oral Tablet | DRUG | Phase 2: Participants will receive Placebo oral tablets for 12 weeks |
Inclusion Criteria: * A historical diagnosis of Type 2 Diabetes in accordance with the American Diabetes Association (ADA) guidelines, with diagnosis at least 6 months prior to Screening. * On a stable (for the last 3 months prior to screening) regimen of metformin monotherapy equivalent of at leas...
TTP399 is an investigational small molecule being developed by vTv Therapeutics Inc. (VTVT) for the treatment of type 1 and type 2 diabetes mellitus. It is a glucokinase activator. The program is in clinical development, with completed Phase 1 and Phase 2 trials in patients with diabetes.
TTP399 is being studied as a treatment for type 1 diabetes mellitus. A completed Phase 1 trial, NCT03335371, evaluated TTP399 in 115 patients with type 1 diabetes in the United States. The drug is investigational and has not been approved for any indication.
TTP399 is a glucokinase activator. It works by activating the glucokinase enzyme, which plays a central role in glucose metabolism and insulin secretion. This mechanism is intended to improve glycemic control in patients with diabetes mellitus.
TTP399 is being developed by vTv Therapeutics Inc., which trades on the Nasdaq under the ticker VTVT. The company is the sponsor of the clinical trials evaluating TTP399 in type 1 and type 2 diabetes.
TTP399 is in clinical development. Completed trials include a Phase 1 study in type 1 diabetes and a Phase 2 study in type 2 diabetes. The drug is investigational and has not been approved by the FDA for any indication.
TTP399 has been evaluated in two completed trials: NCT03335371, a Phase 1 study in 115 patients with type 1 diabetes, and NCT02405260, a Phase 2 study in 190 patients with type 2 diabetes. Both were conducted in the United States.