The compound was well-tolerated, with negligible incidences of nausea and vomiting across all arms of the study. Trends towards weight loss were also observed.
“It is remarkable to see an oral small molecule therapy that demonstrates similar benefits of the injectable diabetes GLP1 drugs without the commonly associated side effects of nausea and vomiting,” said David D’Alessio, M.D., Professor, Department of Medicine and Director, Division of Endocrinology, Metabolism, and Nutrition, Duke University, and vTv Therapeutics Scientific Advisory Board member. “
The convenience of an oral and well-tolerated GLP-1R therapy has the potential to meaningfully expand the treatment options for patients with Type 2 diabetes.”
In the 12-week study conducted in 30 centers in the United States, 174 patients with Type 2 diabetes on stable doses of metformin were randomized to receive either placebo or TTP273 at doses of 150 mg once or twice daily. Patients in the once and twice daily treatment arms had mean placebo-subtracted HbA1c differences of -0.86 percent and -0.71 percent, respectively.
HbA1c increased by 0.15 percent in patients randomized to placebo. Although the study was not powered to demonstrate weight loss, trends were observed with patients losing on average 0.9 kg and 0.6 kg in the once and twice daily arms, respectively. Analyses of full study results will continue.
Steve Holcombe, President and CEO of vTv Therapeutics, said: “TTP273 is the first and only oral small molecule GLP-1R agonist in clinical development. These positive data further validate our novel approach to drug discovery.
“Based on these results, vTv will continue to advance development of TTP273 and enter into discussions with potential partners to bring forward this important potential new therapy for patients with Type 2 diabetes.”
About TTP273
TTP273 is an oral small molecule that works by activating the GLP-1 receptor. Activation of the GLP-1 receptor leads to the enhancement of insulin secretion and suppression of glucagon production and decreased food intake.
There are currently several marketed injectable GLP-1 therapies. These agents have demonstrated notable glucose lowering in addition to weight loss; however, their widespread use may be hindered by the route of administration (injection) and by the high incidence of gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use insulin properly to control sugar in the bloodstream. Type 2 diabetes represents up to 95% of diabetes patients, imposing a growing burden on healthcare systems globally. Diabetes remains the 7th leading cause of death in the United States, costing the healthcare system $245 billion annually. According to the American Diabetes Association, there are 29.1 million Americans, or 9.3% of the population, living with diabetes.