Core Insights - Structure Therapeutics announced positive results from its oral GLP-1 receptor agonist aleniglipron in the ACCESS clinical trial, showing significant weight loss in overweight and obese adults with related complications [4][6] - The ACCESS II study demonstrated a maximum placebo-adjusted average weight loss of 15.3% with a 240mg dose, indicating the drug's tolerability aligns with GLP-1 class characteristics [6] - The company plans to engage with the FDA for a Type B meeting in the first half of next year to finalize the Phase III study protocol [6] Group 1: Clinical Trial Results - In the core IIb ACCESS study, participants receiving 120mg of aleniglipron achieved an average weight loss of 11.3% after 36 weeks, with a 10.4% rate of treatment discontinuation due to adverse events [4] - Among the 120mg group, 86% of participants lost at least 5% of their body weight, and 70% achieved over 10% weight loss [4] - The ACCESS open-label extension results indicated sustained weight loss up to 44 weeks, with improved tolerability when starting at a lower 2.5mg dose [6] Group 2: Safety and Tolerability - No drug-related liver injury, persistent liver enzyme elevation, or QTc prolongation was observed across all studies [6] - An exploratory study with a lower starting dose of 2.5mg showed improved tolerability without any treatment discontinuation due to adverse events during the initial dosing phase [6] Group 3: Future Plans and Market Potential - CEO Raymond Stevens highlighted that the latest results demonstrate aleniglipron's differentiated characteristics, offering clinically meaningful and competitive weight loss with safety suitable for chronic treatment [6] - The drug presents new treatment hope for millions of patients struggling with obesity and related complications [6]
速递|股价一夜大涨102%!硕迪生物公布小分子GLP-1减重2b期临床数据