HIGH POINT, N.C. - vTv Therapeutics Inc . (NASDAQ:VTVT), a clinical-stage biopharmaceutical company, announced today the submission of its phase 3 trial study protocol to the FDA, marking a significant step in the development of its type 1 diabetes drug, cadisegliatin. The trial aims to evaluate the safety and efficacy of cadisegliatin as an adjunctive therapy to insulin in adults with the condition.
The randomized, double-blind, placebo-controlled trial is set to enroll around 150 patients across up to 20 sites in the United States, with the first participant expected to join in the second quarter of 2024.
Patients undergoing treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion, and who use a continuous glucose monitor, will be assessed. The primary goal of the study is to compare the incidence of severe hypoglycemic events between those treated with cadisegliatin and the placebo group.
vTv Therapeutics is also planning a phase 2 trial for patients with type 2 diabetes, scheduled to start in Middle Eastern countries in 2024, in partnership with G42 Healthcare Research Technology Projects LLC and IROS.
Cadisegliatin (TTP399) is a liver-selective glucokinase activator, previously studied in healthy volunteers as well as individuals with type 1 and type 2 diabetes. However, it is not yet licensed or approved for use anywhere in the world.
Thomas Strack, MD, PhD, Chief Medical Officer at vTv Therapeutics, highlighted the urgency for new treatments that can improve glycemic control and enhance the quality of life for patients with type 1 diabetes. The company's recent private placement received strong support from institutional investors, indicating a recognition of this need.
This article is based on a press release statement and provides a summary of vTv Therapeutics' latest steps towards the potential introduction of a new therapeutic option for individuals with diabetes.
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