Tuesday, June 25, 2013

ADA 2013 - TTP054, a novel once daily oral GLP-1 agonist shows efficacy in early stage trials

TTP054 is  an orally bioavailable, potent, non-peptide agonist of GLP-1R for the treatment of type 2 diabetes.  The drug is expected to provide diabetes patients freedom from daily injections and gastrointestinal (GI) side effects have hampered the use of currently marketed GLP-1 agents. 

 The single-center, randomized, placebo-controlled, double-blind trial was intended to examine the effects of 28 days of dosing with TTP054, a novel, orally available GLP-1 agonist, on safety, tolerability, PK and PD.  Subjects with T2DM on stable metformin were enrolled in this trial.

Mean (±SD) age, HbA1c, and BMI were 50±7 yrs, 8.1±1.1 %, and 32±4 kg/m2 respectively. In 3 cohorts, subjects received TTP054 [400 mg QD (n=9), 200 mg BID (n=10), 200 mg QD (n=11)] or placebo (n=18) for 4 wks. Overall, TTP054 was safe and well-tolerated. There were no hypoglycemia AEs, and GI AEs, including nausea and vomiting, were minimal and similar in incidence and severity (mild) in active and placebo groups. 

TTP054 was readily absorbed with a median Tmax of ~3 hrs and a mean terminal t½ of ~6 hrs. PD effects (see table) were consistent with those of injectable GLP-1 agonists (i.e., decrease in glycemic parameters; p<0 .05="" 1="" 3-month="" 400="" all="" assessments="" at="" based="" endpoints="" for="" glycemic="" hba1c="" least="" mg="" modeling="" observed="" of="" on="" p="" predicts="" qd="" reduction="" the="">





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