HUADONG MEDICINE, through its wholly-owned subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. LTD (Zhongmei HuaDong), has recently announced positive results from Phase I clinical trials of its innovative oral small molecule GLP-1 receptor agonist HDM1002 in China.

The Phase Ia trial of HDM1002 in China was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of single-dose, escalating oral administrations of HDM1002 in healthy adult subjects. Total 79 healthy subjects were enrolled. The results showed linear pharmacokinetics within the dose range of 10mg to 600mg for HDM1002, demonstrating good safety and tolerability. The adverse events were all graded as 1 or 2. Postprandial blood glucose levels were significantly reduced in healthy subjects after a single dose compared to the placebo, exhibiting a dose-dependent effect. High-fat meals had no impact on the pharmacokinetics of HDM1002.

The Phase Ib trial of HDM1002 in China was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose, escalating oral administrations of HDM1002 in overweight and obese adult subjects. Total 60 subjects were enrolled. After 28 days of continuous dosing within the dose range of 50-400mg, HDM1002 demonstrated good safety and tolerability. The most common adverse events were gastrointestinal-related, mostly mild nausea and vomiting. Subjects in the 100mg or higher dose groups showed significantly better weight loss compared to the placebo group on day 28, exhibiting a dose-dependent effect. Subjects in the target dose range achieved an average weight loss of 4.9% to 6.8%¹ from baseline by day 28.