Innovent completes first patient dosing in seventh phase 3 trial (GLORY-OSA) of mazdutide

Overview

• Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major disease areas, announced 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 (BMI = 28 kg/m2). 
• This is the seventh phase 3 clinical study of mazdutide 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 study

• GLORY-OSA is a multicenter, randomized, double-blinded phase 3 clinical study (NCT06931028) comparing the efficacy and safety of mazdutide 9mg versus placebo in Chinese participants with moderate-to-severe obstructive sleep apnoea (OSA) and obesity (BMI = 28 kg/m2).
• The primary endpoint is the change in apnoea-hypopnea index (AHI) from baseline to Week 48.

Obstructive sleep apnoea: Globally & in China

• Globally, an estimated 425 million people aged 30 to 69 live with moderate-to-severe OSA, with China bearing the highest burden at approximately 66 million cases. 
• However, the diagnosis rates remain critically low, with less than 1% in China and only 20% in the US. 
• The condition disproportionately affects individuals living with obesity, with a prevalence of 40%, increasing to 80.5% among those undergoing bariatric surgery. 
• OSA-associated co-morbidities, including hypertension, cardiac arrhythmias, stroke, and metabolic syndrome, are strongly correlated with OSA severity.

Treatment options for obstructive sleep apnoea

• Positive airway pressure (PAP) is the first-line treatment for OSA, and certain patients experience transformative benefits from PAP. 
• Challenges exist, however, as many others are unable to accept or adhere to PAP treatment due to the burdensome nature of the therapy. 
• Moreover, current evidence does not strongly support a direct link between PAP and improved cardiometabolic outcomes (e.g., mortality, hypertension, myocardial infarction, stroke). 
• Recently, the FDA approved Zepbound (tirzepatide), a dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonist, as the first and only prescription medicine for moderate-to-severe OSA in adults with obesity. 
• There is currently no approved treatment for OSA in China, highlighting a significant unmet medical need. 
• The literature suggests that a 10% reduction in weight is associated with a 26% decrease in AHI, and that each 1-unit reduction in BMI corresponds to a 2-3 unit decrease in AHI. 
• As such, weight loss medications have emerged as potential treatments for OSA.

Statement from the Principal Investigator

• Professor Tianpei Hong, the Principal Investigator of the Study, Peking University Third Hospital, stated, ""Patients with untreated OSA face significantly increased risks of cardiovascular diseases, metabolic disorders, neurocognitive decline, and traffic accidents. Their quality of life and labour capacity are often severely hampered. The OSA proportion of patients living with obesity is large and grows year after year. Despite this, an effective drug treatment regimen for OSA is lacking in China.” 
• In our phase 3 study GLORY-1, mazdutide showed good weight loss efficacy with multi-cardiovascular metabolism improvement, and a well-tolerated safety profile, which positions mazdutide as the world's first dual GCG/GLP-1 receptor targeted drug for patients with OSA and obesity. I will work closely with the GLORY-OSA research team to ensure the successful and high-quality completion of this study, with the ultimate goal of obtaining robust clinical evidence and expanding treatment options for Chinese patients with moderate-to-severe OSA and obesity.""

Statement from Dr. Lei Qian: Innovent

• Dr. Lei Qian, senior vice president of clinical development at Innovent, stated, ""We have developed different doses and regimens of mazdutide to address the diverse treatment needs of patients with different indications. The development of mazdutide for OSA specifically targets the treatment needs of Chinese patients with moderate-to-severe OSA and obesity (BMI = 28 kg/m2). In a Phase 2 study, mazdutide 9 mg achieved an 18.6 % weight loss compared to placebo, along with notable cardiovascular and metabolic benefits.”
• The 9 mg regimen also features a simple titration schedule and a favourable safety profile. We are optimistic that the GLORY-OSA study will further validate mazdutide’s powerful efficacy and good safety, and provide a promising pharmacologic alternative to PAP, the current standard of care for patients with moderate-to-severe OSA. ""

The exclusive license agreement

• Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. 
• As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. 
• Mazdutide has demonstrated excellent 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.

Current NDAs for Mazdutide

Currently, Mazdutide has two NDAs accepted for review by NMPA, including for:

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

 
Mazdutide is currently 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.

New studies on mazdutide

In addition, several new clinical studies of mazdutide are 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).

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