Innovent Completes First Dosing in Seventh Phase 3 Trial of Mazdutide in China (GLORY-OSA)

SAN FRANCISCO and SUZHOU, China, June 15, 2025 /PRNewswire/ — SAN FRANCISCO and China — Innovent Biologics (HKEX: 01801), a rising star in the biopharmaceutical landscape, has announced a significant milestone in its clinical program. The company has dosed its first participant in a Phase 3 trial, dubbed GLORY-OSA, for mazdutide. This dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist is being evaluated in Chinese patients grappling with obesity and moderate-to-severe obstructive sleep apnea (OSA). This marks the seventh Phase 3 study for mazdutide in China, underscoring Innovent’s commitment to exploring the drug’s potential across a spectrum of metabolic diseases and building a robust body of evidence.

The GLORY-OSA trial is a multi-center, randomized, open-label Phase 3 study (NCT06931028), comparing the efficacy and safety of mazdutide (9mg) against a placebo in a cohort of Chinese participants with moderate-to-severe OSA and obesity (BMI ≥ 28 kg/m²). The primary yardstick for the study’s success will be the change in the apnea-hypopnea index (AHI) from the baseline to Week 48.

The global prevalence of moderate-to-severe OSA is estimated to be a staggering 425 million people aged 30 to 69. Notably, China shoulders the heaviest burden, with approximately 66 million cases, according to a research. Shockingly, diagnosis rates remain critically low. One analysis shows less than 1% in China are diagnosed and only 20% in the U.S. This condition disproportionately affects individuals struggling with obesity, with a prevalence of 40%, soaring to 80.5% among those who undergo bariatric surgery. The consequences are dire: hypertension, cardiac arrhythmias, stroke, and metabolic syndrome are all strongly linked to OSA severity.

While positive airway pressure (PAP) is the current standard of care, compliance and tolerability remain significant hurdles for many patients. Moreover, the impact of PAP on improving cardiometabolic outcomes has been debated recently. The FDA’s recent approval of Zepbound^® (tirzepatide), a GLP-1 and GIP agonist, as treatment for moderate-to-severe OSA in adults with obesity, has opened a new chapter in treatment. However, in China, there’s no approved treatment. Research suggests that weight loss medications could provide a lifeline, with a 10% reduction in weight correlating with a 26% decrease in AHI, and each 1-unit reduction in BMI corresponding to a 2-3 unit decrease in AHI.

Professor Tianpei Hong, Principal Investigator of the Study at Peking University Third Hospital, highlighted the urgent need for effective treatments. “Untreated OSA elevates the risks of cardiovascular problems, metabolic disorders, neurocognitive decline, and accidents, severely impacting quality of life. The prevalence of OSA in patients with obesity is high, yet the absence of effective drug treatment in China is a major unmet medical need. Mazdutide’s favorable weight loss efficacy and cardiovascular metabolism improvement in our Phase 3 study GLORY-1, along with a well-tolerated safety profile, positions mazdutide as a potential game-changer for patients with OSA and obesity. We aim to generate robust clinical evidence and expand treatmentoptions for patients with moderate-to-severe OSA and obesity.”

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, added, “We’ve tailored mazdutide dosages to meet the diverse needs of patients. The GLORY-OSA study is specifically designed to address Chinese patients with moderate-to-severe OSA and obesity (BMI ≥ 28 kg/m²). In a Phase 2 study, mazdutide (9 mg) led to an 18.6% weight loss compared to the placebo, and it demonstrated cardiovascular and metabolic benefits. With a simpler titration schedule and a desirable safety profile, we believe the GLORY-OSA study will further prove mazdutide’s efficacy and provide a promising pharmacologic alternative to PAP, the current standard of care.”

About Mazdutide (IBI362)

Innovent’s collaboration with Eli Lilly and Company for mazdutide (also known as IBI362) has the potential to offer additional benefits beyond traditional GLP-1 receptor agonists. Mazdutide is a GLP-1R and GCGR dual agonist, the compound is designed to promote insulin secretion, lower blood glucose, and reduce body weight while also activating the glucagon receptor to improve energy expenditure and accelerate hepatic fat metabolism. In clinical studies, mazdutide has showcased impressive weight loss and glucose-lowering effects. 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.

The company has two NDAs for Mazdutide under review by NMPA, for the following:

• Long-term weight management in adults with obesity or overweight.
• Glycemic control in adults with type 2 diabetes (T2D).

Currently, Mazdutide is being evaluated in seven Phase 3 clinical studies, including:

• GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity.
• GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity.
• GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD).
• GLORY-OSA: A Phase 3 trial in Chinese participants with OSA and obesity.
• DREAMS-1: A Phase 3 trial in treatment-naïve Chinese participants with T2D.
• DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D participants with inadequate glycemic control on oral antidiabetic drugs.
• DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with T2D and obesity.

Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing.

Innovent has many clinical trials initiated or planned, including:

• A Phase 3 trial in adolescents with obesity.
• New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF).

About Innovent

Founded in 2011 with a clear mission, Innovent is committed to providing patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures, and commercializes innovative medicines, targeting some of the most challenging diseases. Their current portfolio includes 15 marketed products, with three new drug applications under regulatory review, four assets in Phase III or pivotal clinical trials, and 15 more molecules in early clinical stages. Innovent has built partnerships with over 30 global healthcare companies and research institutions.

Innovent’s motto is “Start with Integrity, Succeed through Action” and their goal is to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. Learn more at www.innoventbio.com.

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