The prospective, randomized, double-blind, placebo-controlled Phase IIa trial is designed to enroll up about 24 patients with type 1 diabetes in-clinic for ten days.
During the trial, patients will be randomized in a 2:1 ratio to receive either ORMD-0801 or placebo.
The trial’s primary endpoint is to assess the change from baseline in exogenous insulin requirements (basal, bolus, and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.
Secondary endpoints of the trial include evaluating the change from baseline in mean nighttime, daytime, and fasting glucose levels in type 1 diabetes patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.
Oramed Pharmaceuticals CEO Nadav Kidron said the company is pleased to be initiating this US clinical trial with ORMD-0801 in patients with type 1 diabetes following successful trials outside of the US.
"This initiation is in parallel to the company gearing up for its multi-center Phase IIb study for the treatment of type 2 diabetics," Kidron said.