Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-OSA) of mazdutide, a dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese participants with moderate-to-severe obstructive sleep apnoea (OSA) and obesity.
This is mazdutide's seventh Phase 3 clinical study in China, continuing to explore its potential in managing obesity and a range of metabolic syndromes, with the aim of generating more comprehensive and high-quality evidence to support clinical application.
GLORY-OSA is a multicentre, randomised, double-blinded Phase 3 clinical study comparing the efficacy and safety of mazdutide 9mg versus placebo in Chinese participants with moderate-to-severe OSA and obesity (BMI greater than or equal 28 kg/m2). The primary endpoint is the change in apnoea-hypopnea index (AHI) from baseline to Week 48.
Innovent has an exclusive licence agreement with Eli Lilly and Company (NYSE:LLY) for the development and potential commercialisation of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China.
Mazdutide has demonstrated weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity.
Currently, mazdutide has two NDAs accepted for review by Chinese regulator NMPA: for long-term weight management in adults with obesity or overweight, and for glycaemic control in adults with type 2 diabetes (T2D).
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