HUADONG MEDICINE Announces Positive Phase I Results for Innovative Oral Small Molecule GLP-1 Receptor Agonist 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.
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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.

About HDM1002 Tablet

HDM1002 is an innovative small molecule drug independently developed by Zhongmei HuaDong with global intellectual property rights. It is an orally active, potent, and highly selective small molecule full agonist of the GLP-1 receptor. Preclinical studies have shown that HDM1002 can potently activate the GLP-1 receptor, induce the production of cAMP, and exhibit strong effects in improving glucose tolerance, reducing blood sugar, promoting weight loss, demonstrating good safety.

HDM1002's IND application for the treatment of diabetes was approved in both China and US in May 2023. The IND application for the weight loss indication was approved in China in September 2023. In May 2024, the enrollment of all subjects for Phase II in China was completed.

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