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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 for the treatment of Type 1 and Type 2 diabetes mellitus. It is a glucokinase activator, which means it targets the glucokinase enzyme to help regulate blood sugar levels. The drug is currently in clinical development and has not been approved by the FDA.
TTP399 targets glucokinase, an enzyme that plays a key role in glucose metabolism. By activating glucokinase, TTP399 aims to enhance glucose sensing and utilization in the body, which may help improve glycemic control in patients with diabetes. This mechanism is being studied in both Type 1 and Type 2 diabetes.
TTP399 is being developed by vTv Therapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of TTP399 in patients with diabetes. vTv Therapeutics is publicly traded under the ticker symbol VTVT.
TTP399 is in Phase 1 clinical development. The most recent trial, NCT03335371, was a Phase 1 study in patients with Type 1 diabetes. An earlier Phase 2 trial, NCT02405260, was also completed. The drug is investigational and has not received FDA approval.
TTP399 has been studied in two completed clinical trials. NCT02405260 was a Phase 2 trial in 190 patients with Type 2 diabetes, and NCT03335371 was a Phase 1 trial in 115 patients with Type 1 diabetes. Both trials were conducted in the United States and were randomized, double-blind, and placebo-controlled.
Yes, TTP399 is a glucokinase activator. It works by activating the glucokinase enzyme, which is involved in glucose metabolism. This mechanism is being investigated for its potential to improve blood sugar control in people with Type 1 and Type 2 diabetes.