HANGZHOU, China, June 26, 2024 /PRNewswire/ -- 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.
1.
Least Squares Means, the estimates from Mixed models for
repeated measures
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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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