Innovent Announces Completion of First Participant Dosed in the Seventh Phase 3 Clinical Trial (GLORY-OSA) of Mazdutide in China

Rhea-AI Summary

Innovent Biologics has initiated dosing in GLORY-OSA, its seventh Phase 3 clinical trial of mazdutide in China. The study evaluates mazdutide 9mg, a dual GCG/GLP-1 receptor agonist, for treating moderate-to-severe obstructive sleep apnea (OSA) in obese patients. The multicenter, randomized trial aims to assess efficacy against placebo, with primary endpoint measuring change in apnea-hypopnea index at 48 weeks. This development is significant as China has the highest OSA burden globally with 66 million cases, yet lacks approved treatments. Previous Phase 2 results showed mazdutide 9mg achieved 18.6% weight loss versus placebo, with cardiovascular and metabolic benefits. The drug could potentially offer an alternative to positive airway pressure therapy, addressing a major unmet medical need in China's OSA treatment landscape.

Positive

• Phase 2 study demonstrated strong 18.6% weight loss efficacy compared to placebo
• Targeting large market opportunity with 66 million moderate-to-severe OSA cases in China
• Could become first approved OSA treatment in China, addressing significant unmet need
• Showed notable cardiovascular and metabolic benefits in previous studies
• Simple titration schedule and favorable safety profile reported

Negative

• Faces competition from recently FDA-approved Zepbound (tirzepatide) in OSA treatment
• Currently in Phase 3 with results pending, success not guaranteed
• Low OSA diagnosis rates in China (less than 1%) may impact market penetration

SAN FRANCISCO and SUZHOU, China, June 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), 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 apnea (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 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06931028) comparing the efficacy and safety of mazdutide 9mg versus placebo in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity (BMI ≥ 28 kg/m²).The primary endpoint is the change in apnea-hypopnea index (AHI) from baseline to Week 48.

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^[1]. However, the diagnosis rates remain critically low, with less than 1% in China and only 20% in the U.S.^[2],[3] The condition disproportionately affects individuals living with obesity, with a prevalence of 40%, increasing to 80.5% among those undergoing bariatric surgery^[4],[5]. OSA-associated co-morbidities, including hypertension, cardiac arrhythmias, stroke, and metabolic syndrome, are strongly correlated with OSA severity^[6],[7].

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)^[8]. 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^[9]. There is currently no approved treatment for OSA in China^[1], highlighting a significant unmet medical need. The literature suggests^{[10],[11],[12]} 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.

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 labor 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^[13]. In our Phase 3 study GLORY-1^[14], 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."

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 favorable 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."

About Mazdutide (IBI362)

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.

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.

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).

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

References

[1] Benjafield AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019;7(8):687-698. doi:10.1016/S2213-2600(19)30198-5

[2] Zhang Y, et al. Underdiagnosis of Sleep Apnea in China: A Call for Public Health Action. Chest. 2022;161(2):418-426.

[3] Kapur VK, et al. Underdiagnosis of Sleep Apnea in U.S. Adults. Am J Respir Crit Care Med. 2017;196(3):285-286.

[4] 成人阻塞性睡眠呼吸暂停高危人群筛查与管理专家共识.中华健康管理学杂志, 2022,16(8) : 520-528.

[5] 成人阻塞性睡眠呼吸暂停基层诊疗指南. 中华全科医师杂志，January 2019, Vol. 18, No.1

[6] 肖毅. 中华结核和呼吸杂志, 2019,42(8) : 561-563.

[7] Alakörkkö I, et al. The economic cost of obstructive sleep apnea: A systematic review. Sleep Med Rev. 2023 Dec;72:101854.

[8] Malhotra A, Bednarik J, Chakladar S, et al. Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024;141:107516. doi:10.1016/j.cct.2024.107516

[9] https://lilly.mediaroom.com/2024-12-20-FDA-approves-Zepbound-R-tirzepatide-as-the-first-and-only-prescription-medicine-for-moderate-to-severe-obstructive-sleep-apnea-in-adults-with-obesity

[10] Araghi MH, et al. Sleep. 2013 Oct 1;36(10):1553-62, 1562A-1562E.

[11] Peppard PE, et al. JAMA. 2000 Dec 20;284(23):3015-21.

[12] Romero-Corral A, et al. Chest. 2010 Mar;137(3):711-9.

[13] Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004–18

[14] Ji L, et al. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528.

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SOURCE Innovent Biologics

FAQ

What is the primary endpoint of IVBIY's GLORY-OSA Phase 3 trial for mazdutide?

The primary endpoint is the change in apnea-hypopnea index (AHI) from baseline to Week 48

How effective was mazdutide 9mg in Phase 2 trials for OSA treatment?

Mazdutide 9mg achieved an 18.6% weight loss compared to placebo, along with cardiovascular and metabolic benefits

What is the market size for OSA treatment in China?

China has approximately 66 million cases of moderate-to-severe OSA, the highest burden globally

How does mazdutide work for OSA treatment?

Mazdutide is a dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist that helps treat OSA through weight loss, as a 10% reduction in weight is associated with a 26% decrease in AHI

What advantages could mazdutide offer over current OSA treatments?

Mazdutide could provide a pharmacologic alternative to positive airway pressure (PAP) therapy, which has adherence challenges, and could be the first approved OSA treatment in China