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
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.