vTv Therapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, has announced the enrollment of the first patients in the company’s phase II LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.
The previous phase Ib trial of TTP273 demonstrated robust effects on postprandial and fasting glucose. All doses of TTP273 were safe and well tolerated with no serious adverse events or evidence of gastrointestinal side effects compared to placebo.
“Earlier studies of this compound showed that TTP273 has the potential to provide enhanced glycemic control and weight loss without the burden of injections or gastrointestinal side effects seen with GLP-1 biologic agents,” said Steve Holcombe, president and CEO of vTv. “TTP273 is just one of two diabetes treatments in our pipeline reading out this year with our best-in-class orally administered Glucokinase Activator, TTP399, expected to report phase II results in mid-2016.”
The LOGRA study is assessing the safety and efficacy of TTP273 in type 2 diabetic patients on stable doses of metformin. The study’s primary endpoint is change in baseline in HbA1c at 3 months, with secondary endpoints including body weight, plasma glucose, lipids insulin, lactate, C-peptide, glucagon and GLP. The company anticipates enrolling 156 patients at 26 clinical trial sites throughout the U.S. Topline results are expected at the end of 2016.