Shenzhen HighTide Biopharmaceutical, Ltd a globally integrated clinical-stage biotechnology company developing drugs with multi-functional biological actions to address the complex pathophysiology of metabolic and digestive diseases, announced that the first patient was dosed in a phase 2 study evaluating HTD1801 in patients with type 2 diabetes mellitus (T2DM) in China.
The objective of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of HTD1801 in 99 adult subjects with T2DM, with a specific focus on the therapeutic effects of HTD1801 on patients with comorbid type 2 diabetes mellitus and nonalcoholic fatty liver disease (T2DM+NAFLD). The primary endpoint is the change in hemoglobin A1c (HbA1c) after 12 weeks of treatment, and secondary endpoints include changes in markers of NAFLD, liver function, and metabolic parameters.
