Core Insights - MindRank announced positive topline results from a Phase 2b clinical trial of its AI-designed oral GLP-1 receptor agonist, MDR-001, for obesity treatment in China [1][6] Study Results - The 24-week, randomized, placebo-controlled study showed that participants receiving MDR-001 experienced mean body weight reductions of 8.2% to 10.3% (7.4-9.2 kg) compared to 2.5% (2.4 kg) in the placebo group, with a statistically significant p-value of <0.00001 [2][8] - Placebo-adjusted weight loss ranged from 7.1% to 7.8%, with 70.9% to 85.4% of participants achieving at least 5% weight loss and 34.5% to 48.1% achieving at least 10% weight loss [2][8] Cardiometabolic Benefits - MDR-001 also led to significant improvements in key cardiometabolic markers, including waist circumference, blood pressure, and lipid profiles, indicating its potential as a comprehensive metabolic therapy [3] Safety and Tolerability - The treatment was well tolerated, with no serious adverse events reported. The most common mild to moderate treatment-emergent adverse events were gastrointestinal symptoms, primarily during the initial 6-week dose-escalation period [4][5] - Hepatic safety analyses showed no transaminase elevation, even in participants with pre-existing liver impairment, and ALT and AST levels were significantly reduced compared to placebo [5] Future Development - The positive Phase 2b data supports the progression of MDR-001 to Phase 3 trials, with ongoing exploration of once-daily dosing regimens to enhance patient convenience [6][9] - MDR-001 is the first AI-designed oral GLP-1RA to report positive Phase 2b data globally, laying a solid foundation for late-stage development and potential partnerships to address the global obesity epidemic [6][10]
MindRank Announces Positive Phase 2b Results for AI-Designed Oral GLP-1 Receptor Agonist MDR-001 in Adults with Obesity or Overweight
Globenewswire·2025-06-24 12:00