Second Head-to-head Phase 3 Study of Mazdutide versus Semaglutide Completes First Participant Dosing in Adults in China with Overweight or Obesity Accompanied Fatty Liver Disease (GLORY-3)
GLORY-3 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06884293) comparing the efficacy and safety of mazdutide versus semaglutide in Chinese adults with overweight or obesity accompanied MAFLD. This study plans to enroll approximately 470 participants with overweight or obesity (BMI ≥ 27 kg/m2) accompanied MAFLD, who will be randomized 1:1 to receive mazdutide 9 mg or semaglutide 2.4 mg. The primary endpoints are the percentage change in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction (MRI-PDFF) and the percentage change in body weight from baseline to week 48.
A Phase 2 study conducted in Chinese adults with obesity (BMI ≥ 30 kg/m2, NCT04904913) showed that after 48 weeks of treatment, mazdutide 9 mg achieved an 18.6% (17.8kg) placebo-adjusted mean percent reduction in body weight. Meanwhile, 51.2% and 34.9% of the subjects in the mazdutide 9 mg group achieved 15% or more and 20% or more weight loss from baseline, respectively. Among participants with baseline LFC≥ 5% (measured by MRI-PDFF), the percent change in LFC from baseline to week 24 was reduced by 73.3% in the mazdutide 9 mg group. This decrease was sustained during the 48-week extended treatment period, suggesting that mazdutide can effectively reduce body weight and liver fat in participants with overweight or obesity.
Professor Lixin Guo, the Principal Investigator of the Study, Peking University People's Hospital, stated, "MAFLD is now the most common chronic liver disease in the world and has surpassed viral hepatitis as the leading chronic liver disease in China. Obesity is a key risk factor, with MAFLD affecting up to 81.8% people with obesity in China[1]. The latest Chinese guidelines recommended GLP-1 agents such as semaglutide for treating obesity and MAFLD ('Guideline for chronic weight management and clinical practice of anti-obesity medications'). As a dual GCG/GLP-1 receptor agonist, mazdutide 9 mg has shown strong weight loss effects and notable improvements in liver fat and enzyme levels, thanks to its additional GCG activity. GLORY-3 is the first clinical trial comparing a dual GCG/GLP-1 receptor agonist with a GLP-1R-only drug in Chinese adults with obesity. It will compare the efficacy and safety of mazdutide 9 mg versus semaglutide 2.4 mg in participants with overweight or obesity accompanied MAFLD. Together with our investigator team, I am committed to conducting this study to the highest standards and to delivering a better treatment option for the Chinese population with overweight or obesity accompanied MAFLD."
Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, stated, "Mazdutide, as a dual GCG/GLP-1 receptor agonist, enhances lipolysis and fatty acid oxidation by stimulating the GCG receptor, offering a series of comprehensive metabolic benefits compared to GLP-1 single receptor agonist drugs. In our Phase 2 study conducted in Chinese adults with obesity, participants with baseline LFC ≥ 5% had a 73.3% reduction in liver fat content after 24 weeks of treatment with mazdutide 9 mg, which preliminarily demonstrated the efficacy of mazdutide in reducing liver fat content. I am very confident that mazdutide will continue to show strong clinical efficacy in the GLORY-3 study, including in weight loss and liver metabolism, and provide a better treatment option for Chinese patients with overweight or obesity accompanied MAFLD."
About Obesity
China has the world's largest population of people with overweight or obesity[2], with the obesity rate likely to rise. Obesity contributes to multiple comorbidities, reducing life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths related from chronic non-communicable diseases in China, a significant increase from 5.7% in 1990[3].
As obesity is a chronic disease, it requires long-term management, and China faces a lack of long-term effective and safe treatments. Despite lifestyle interventions being the first-line treatment, many patients fail to achieve their desired weight loss goals, underscoring the need for more effective and safer pharmacological interventions.
About MAFLD
MAFLD is the most common chronic liver disease worldwide, with a global prevalence estimated around 32.4% and increasing. Obesity is one of the risk factors for MAFLD, and the prevalence of MAFLD in those with obesity worldwide has reached 75.3%. In China, MAFLD has overtaken viral hepatitis as the leading chronic liver condition, affecting 81.8% of obese individuals[1]. China also has the world's highest incidence of MAFLD in both normal and obese populations. Treatment goals include reducing body weight and waist circumference, improving insulin resistance, preventing and treating metabolic-related syndromes, and reversing fibrosis. For patients with MAFLD and overweight or obesity, combining lifestyle and pharmacological interventions is considered the most effective strategy to improve health outcomes and quality of life.
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.
Mazdutide currently has two NDAs accepted for review by NMPA, including:
For chronic weight management in adults with overweight of obesity;
For glycemia control in adults with type 2 diabetes.
Mazdutide is currently being evaluated in six 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).
DREAMS-1: A Phase 3 trial in treatment-naïve Chinese patients with T2D.
DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D patients with inadequate glycemic control on oral antidiabetic drugs.
DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese patients with T2D and obesity.
Among these, GLORY-1, DREAMS-1 and DREAMS-2 studies have all met their endpoints.
In addition, several new clinical studies of mazdutide are planned, including:
A Phase 3 trial in adolescents with obesity.
A Phase 3 trial in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and 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, Adimab, 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.
Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.
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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions.
Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect.
References
[1] Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399.
[2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.
[3] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).
View original content:https://www.prnewswire.com/apac/news-releases/second-head-to-head-phase-3-study-of-mazdutide-versus-semaglutide-completes-first-participant-dosing-in-adults-in-china-with-overweight-or-obesity-accompanied-fatty-liver-disease-glory-3-302456570.html
SOURCE Innovent Biologics
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Boston Globe
an hour ago
- Boston Globe
As the dollar slides, the Euro is picking up speed
'We are witnessing a profound shift in the global order: Open markets and multilateral rules are fracturing, and even the dominant role of the U.S. dollar, the cornerstone of the system, is no longer certain,' she wrote last month. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up The dollar's role as the world's reserve currency gives the United States an 'exorbitant privilege' — a term coined begrudgingly by a French politician in the 1960s. Because investors, governments and central banks around the world seek the safe, predictable returns of dollar-denominated assets such as Treasury bonds, there is a robust, built-in demand for dollars. That makes it easier for the U.S. government to borrow and boosts the spending power of American consumers. Advertisement The eurozone, which is made up of the 20 countries that use the euro and rivals the United States in terms of size and wealth, has never attracted investors in the same way. The euro ranks a distant second to the dollar in global use. Advertisement The euro's recent rise is a major reversal from just three years ago, when it dropped to parity with the dollar because investors feared the damage of surging inflation and Russia's invasion of Ukraine. And it is a world away from the eurozone debt crisis last decade, when at times the currency union seemed at risk of crumbling. As welcome as the euro's recovery from those episodes has been — the euro is trading near a record high against the currencies of dozens of major trading partners — it is also possible to have too much of a good thing. As money flows into the euro and euro-denominated assets such as German government bonds, economists and executives warn that the currency's strength could hurt exporters. They are already contending with Trump's tariffs, which make their goods more expensive for buyers abroad, as well as increased competition from Chinese rivals in key markets. 'Further euro strength is likely to be self-defeating,' said Valentin Marinov, a currency strategist at Crédit Agricole, a French bank. Exports were already likely to weaken and become a drag on the eurozone economy because of U.S. tariffs and European government policies that would encourage more imports. After a surge in energy prices led to years of fighting to bring inflation down, the European Central Bank, which sets interest rates for the eurozone, now faces the prospect that inflation could be too low. The bank forecasts inflation to average 1.6% next year, notably below its 2% target. That's partly because of the impact of a strong euro, which makes imports cheaper. Advertisement Some policymakers have said there is a risk that sluggish inflation will become entrenched, which is a familiar problem for the region. For nearly a decade until 2021, the central bank kept its key interest rates below zero in hopes of spurring faster economic growth and encouraging prices to rise steadily. That, policymakers hoped, would feed through to higher wage growth and better living standards. ECB officials are expected to keep interest rates steady when they meet this week, but analysts are adding to bets they could cut rates again later this year, if the economic outlook darkens or the euro's strength pushes inflation forecasts even lower. Reducing interest rates tends to weaken a currency, but the euro's recent strength has come, notably, as the ECB cut rates eight times in a year. Luis de Guindos, the vice president of the central bank, said that if the euro climbed above $1.20, that 'would be much more complicated.' Some big European companies have warned about the effect of the strong currency on their earnings, especially in export-heavy Germany. SAP, a software firm that recently became Europe's most valuable public company, said every 1-cent increase in the euro-dollar exchange rate results in a 30 million euro decline in revenues, without currency hedges. Adidas, the sportswear brand, said a strong euro had 'negative translation effects' on its overseas sales. Daimler, a truck maker, said fluctuations in the euro-dollar rate 'could significantly impact' its financial performance. Where the euro goes next is hard to predict. Analysts surveyed by Bloomberg expect the euro to continue strengthening, to $1.21 next year. But Marinov said he believed that traders had gotten ahead of themselves: He expects the euro to fall back toward $1.10 next year. Advertisement The currency's rally this year does not necessarily mean there will be a lasting shift toward the euro, in which it accounts for a larger share of central banks' reserves or is used in more cross-border payments. Lagarde said seizing the moment for a 'global euro' would take a concerted effort to bolster the bloc's fragmented economy, streamline its governance and deepen its capital markets, among other things. 'A step towards greater international prominence for our currency will not happen by default: It must be earned,' she said. This article originally appeared in .
Business Wire
an hour ago
- Business Wire
NIQ Announces Pricing of Initial Public Offering
CHICAGO--(BUSINESS WIRE)--NIQ Global Intelligence plc (the 'Company') announced today the pricing of its initial public offering of 50,000,000 of its ordinary shares at a public offering price of $21.00 per ordinary share. The underwriters will have a 30-day option to purchase up to an additional 7,500,000 ordinary shares from the selling shareholder at the initial public offering price less underwriting discounts and commissions. The Company's ordinary shares are expected to begin trading on the New York Stock Exchange on July 23, 2025, under the ticker symbol 'NIQ.' The offering is expected to close on July 24, 2025, subject to customary closing conditions. The Company intends to use the net proceeds that it receives from the offering, together with available cash, as necessary, to repay amounts outstanding under its revolving credit facility and a portion of the amounts outstanding under its US term loan facility and to use any remaining net proceeds for working capital and for general corporate purposes. The Company will not receive any proceeds from the sale of ordinary shares by the selling shareholder. J.P. Morgan, BofA Securities, UBS Investment Bank, Barclays and RBC Capital Markets are acting as joint lead book-running managers for the offering. Citigroup, Wells Fargo Securities, BNP Paribas, Deutsche Bank Securities, BMO Capital Markets and KKR are also acting as joint book-running managers. Baird, Needham & Company, Stifel, William Blair, Capital One Securities, Fifth Third Securities, SMBC Nikko, Academy Securities, Loop Capital Markets and Roberts & Ryan are acting as co-managers for the offering. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or email: prospectus-eq_fi@ and postsalemanualrequests@ BofA Securities, Inc., NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, by email: or UBS Securities LLC, 1285 6th Ave, New York, NY 10019, by telephone: (888) 827-7275. A registration statement on Form S-1 relating to the offering was declared effective by the Securities and Exchange Commission on July 22, 2025. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About NIQ NIQ is a leading consumer intelligence company, delivering the most complete understanding of consumer buying behavior and revealing new pathways to growth. NIQ combined with GfK in 2023, bringing together two industry leaders with unparalleled global reach. Our global reach spans over 90 countries covering approximately 85% of the world's population and more than $ 7.2 trillion in global consumer spend. With a holistic retail read and the most comprehensive consumer insights—delivered with advanced analytics through state-of-the-art platforms—NIQ delivers the Full View™. NIQ-IR
Yahoo
2 hours ago
- Yahoo
Why Nio Stock Skyrocketed Today
Key Points Nio stock announced a new SUV line, and the news powered big gains for its stock today. Nio's ONVO L90 will debut with a normal model and a cheaper, battery-as-a-service model. The Chinese EV specialist looks cheap on a price-to-sales basis, but it's a risky play in the EV market. 10 stocks we like better than Nio › Nio (NYSE: NIO) stock rocketed higher in Tuesday's trading following the announcement of a new vehicle. The company's share price closed out the daily session up 11%, despite a 0.4% decline for the Nasdaq Composite index in the session. Nio's valuation surged today after the company announced its new three-row SUV model. With today's pop, the stock is now up roughly 15% across this year's trading. Nio stock surges on ONVO L90 SUV announcement Nio is rolling out its new ONVO L90 model for the Chinese market on Aug. 1. The vehicle will be rolled out at two price points -- a $39,000 complete model and a $27,000 battery-as-a-service model. The company's revenue increased 21.5% year over year in the first quarter, and investors are betting that the rollout of the company's new SUV will boost vehicle deliveries and allow the business to tap into high-margin service-based revenue streams. What's next for Nio? Despite the recent rally, Nio stock is still down roughly 76% over the last three years -- and the company is valued at just 90% of this year's expected revenue. Given that Tesla is currently trading at approximately 11 times this year's expected sales, Nio's price-to-sales ratio could look quite cheap at current levels. For starters, Nio has yet to shift into profitability. The stock also comes with some big geopolitical risk factors connected to the increasingly adversarial relations between the U.S. and China. Nio could wind up delivering big wins for investors if the business' deliveries continue to expand at recent rates, but it's a risky play. Do the experts think Nio is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did Nio make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,055% vs. just 180% for the S&P — that is beating the market by 874.27%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $665,092!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,050,477!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 21, 2025 Keith Noonan has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Tesla. The Motley Fool has a disclosure policy. Why Nio Stock Skyrocketed Today was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
