SAN FRANCISCO and SUZHOU, China, Dec. 17, 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 oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the results of two Phase 3 clinical studies of mazdutide, the world's first approved glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist, in Chinese adults with type 2 diabetes (T2D) (DREAMS-1, DREAMS-2) have been published back-to-back in Nature as Accelerated Article Previews (AAP) [DREAMS-1^i,DREAMS-2ⁱⁱ].

The co-first authors of the DREAMS-1 article are Professor Dalong Zhu from Nanjing Drum Tower Hospital affiliated with Nanjing University Medical School, and Professor Jiajun Zhao from Shandong Provincial Hospital affiliated with Shandong First Medical University. Dr. Lei Qian from Innovent Biologics serves as co-corresponding author alongside both co-first authors. For the DREAMS-2 article, the co-first authors are Professor Lixin Guo from Beijing Hospital and Professor Bo Zhang from China-Japan Friendship Hospital, with Professor Wenying Yang from China-Japan Friendship Hospital serving as the corresponding author.

The Nature publication of mazdutide represents multiple historic breakthroughs. It marks the first time that Nature has published two Phase 3 clinical studies back-to-back in the field of metabolic and endocrine diseases, and mazdutide became the first China-developed drug to have two studies published simultaneously in Nature. Notably, mazdutide's first Phase 3 weight loss clinical study (GLORY-1) were published in The New England Journal of Medicine, making it the only GLP-1 therapy to reach the top journals of both Nature and NEJM. This achievement signifies the highest level of international academic recognition for China's drug development and biotech innovation. With its robust clinical data and groundbreaking mechanistic studies, mazdutide provides a "China Solution" in the global metabolic disease space. Together, Chinese clinicians and Innovent as a China-leading innovative pharmaceutical company, have made a significant contribution to China's "Weight Management Year" and "Healthy China" strategy, one that demonstrates both substantial clinical value and international impact.

This publication as Accelerated Article Preview (AAP) in Nature underscores international premium journal's recognition of mazdutide's two landmark studies. AAP is a system that rapidly releases high-impact, peer-reviewed research online before formal print publication. It provides immediate access to citable typeset manuscripts, serving both authors and the scientific community by accelerating the dissemination of important findings and enabling researchers to promptly access and cite these outcomes.

Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, stated, "Mazdutide is the world's first approved GCG/GLP-1 dual receptor agonist for both glycemic control and weight management. Following the publication of its Phase 3 weight management study (GLORY-1) in The New England Journal of Medicine (NEJM) this May, our landmark findings from the DREAMS-1 and DREAMS-2 trials have now been published back-to-back in Nature as Accelerated Article Previews (AAP). This represents a pivotal milestone for China's metabolic clinical research, delivering high-level evidence-based medicine for Chinese T2D patients while demonstrating our robust clinical development capabilities as one of China's leading biopharmaceutical innovators. These pivotal findings are expected to inform global clinical guidelines and practice. With mazdutide now approved in China for both indications, patients gain access to advanced therapeutic options. Multiple indication explorations and registration studies of mazdutide are currently underway, paving the way for further breakthroughs. Upholding our mission, Innovent will continue to deepen its commitment to innovation and collaborate broadly to improve lives and support the goals of 'Healthy China 2030'."

Mazdutide, the globally first and only approved GCG/GLP-1 dual receptor agonist, received approvals from China's NMPA for weight management and glycemic control in June and September 2025, respectively. Supported by its innovative mechanism and robust clinical evidence, its first Phase 3 weight loss clinical study (GLORY-1) was published in NEJM in May 2025ⁱⁱⁱ and incorporated into China's clinical consensus guidelines for obesity and diabetes management. Its two Phase 3 glycemic control clinical studies have now been published in Nature. These landmark studies are expected to inform global diabetes treatment guidelines, reinforcing mazdutide's scientific and clinical significance.

The two Phase 3 studies published in Nature respectively demonstrated the efficacy and safety of mazdutide monotherapy (DREAMS-1, NCT05628311) and add-on therapy to oral anti-diabetic drugs (DREAMS-2, NCT05606913) in Chinese adult participants with T2D. Both trials established mazdutide's statistically significant superiority versus comparators (placebo or dulaglutide 1.5 mg) in glycemic control and weight loss, while demonstrating metabolic improvements across cardiometabolic, hepatic, and renal indicators.

In DREAMS-1, 320 Chinese adults with T2D inadequately controlled with diet and exercise alone (mean age 50.4 years; baseline HbA_1c 8.24%; weight 77.7 kg) were randomized to receive mazdutide 4 mg, 6 mg, or placebo for 24 weeks. Following the double-blind period, participants in mazdutide groups continued their assigned regimen, while participants in the placebo group were switched to mazdutide 6 mg for an additional 24-week extended treatment period. The primary endpoint was the change from baseline in HbA_1c at Week 24.

DREAMS-2 enrolled 731 Chinese adults with T2D who had insufficient glycemic control on metformin alone or in combination with metformin-based therapy (mean age 51.8 years; baseline HbA_1c 8.22%; weight 76.95 kg). Participants were randomized 1:1:1 to receive mazdutide 4 mg, mazdutide 6 mg, or dulaglutide 1.5 mg for 28 weeks. The primary efficacy endpoint was the change from baseline in HbA_1c at Week 28.

Mazdutide achieves clinically significant 2.02% HbA_1c reduction at Week 24

In the DREAMS-1 trial, under the treatment-policy estimand analysis, the adjusted least-squares (LS) mean changes in HbA_1c from baseline at Week 24 were -1.58% for mazdutide 4 mg, -2.02% for mazdutide 6 mg, and -0.25% for placebo, respectively. The proportions of participants achieving HbA_1c <7% were 66.4% and 81.8% with mazdutide 4 mg and 6 mg, respectively, versus 11.7% with placebo. These findings were consistent with the efficacy estimand analysis.

In the DREAMS-2 trial, under the treatment-policy estimand analysis, the adjusted LS mean changes in HbA_1c from baseline were -1.61% for mazdutide 4 mg, -1.66% for mazdutide 6 mg, and -1.36% for dulaglutide 1.5 mg at Week 28, respectively. The proportion of participants achieving HbA_1c <7% were 67.7% and 70.4% with mazdutide 4 mg and 6 mg, respectively, versus 61.6%. These findings were consistent with the efficacy estimand analysis.

Mazdutide demonstrated dual superiority in both glycemic control and weight loss versus comparators

In DREAMS-1, under the treatment-policy estimand analysis, the adjusted LS mean percentage weight changes from baseline at Week 24 were -5.50% for mazdutide 4 mg, -7.34% for mazdutide 6 mg, and -1.15% for placebo, respectively. The proportion of participants achieving ≥5% weight loss were 48.8%, 64.0%, and 6.6%, respectively, with 39.0%, 58.5%, and 0% achieving both HbA_1c <7% and ≥5% weight loss. These outcomes were consistent with the efficacy estimand analyses.

DREAMS-2 results similarly demonstrated mazdutide's superiority over dulaglutide 1.5 mg in weight loss at Week 28, showing adjusted LS mean percentage changes of -6.55%, -8.53%, and -2.77% for mazdutide 4 mg, 6 mg, and dulaglutide 1.5 mg groups, respectively. The proportions achieving ≥5% weight loss were 58.6%, 73.1%, and 26.6%, respectively, with 46.9%, 59.9%, and 18.9% achieving both HbA_1c <7% and ≥5% weight loss. These outcomes were consistent with the efficacy estimand analyses.

Mazdutide demonstrated multiple cardiometabolic benefits

Both trials revealed significant and clinically meaningful improvements across multiple parameters including fasting plasma glucose, seven-point self-monitored blood glucose profiles, waist circumference, blood pressure, lipid profiles, and liver enzyme levels, demonstrating GCG's advantages. Notably, compared to western populations, Chinese population typically have lower BMI (body mass index) but exhibit a more pronounced prevalence of central obesity. Mazdutide effectively addresses this by suppressing hepatic fat synthesis while enhancing intrahepatic lipolysis, enabling substantial weight reduction—particularly beneficial for the Chinese population, who are more prone to visceral fat accumulation.

Mazdutide demonstrated a favorable safety profile  consistent with prior findings

No new safety signals were identified across either study. The most frequently reported treatment-emergent adverse events were gastrointestinal, predominantly mild-to-moderate in severity and transient in nature, with peak incidence occurring during titration. Notably, no severe hypoglycemia events were reported by participants with mazdutide, with incidences of mild-to-moderate (Grade 1‒2) hypoglycemia similar to dulaglutide 1.5 mg.

Mazdutide met primary endpoints in another Phase 3 DREAMS-3 trial in this October. DREAMS-3 is the world's first Phase 3 clinical trial of a GCG/GLP-1 dual receptor agonist to conduct a head-to-head comparison with semaglutide in diabetes treatment. The results demonstrated that, mazdutide showed superior efficacy to semaglutide on the primary endpoint—at Week 32, the proportion of participants achieving HbA_1c < 7.0% and ≥10% body weight reduction from baseline at week 32 (48.0 vs. 21.0%, p<0.0001).

About diabetes

China currently bears the world's highest diabetes burden, with the International Diabetes Federation (IDF) 2025 Diabetes Atlas estimating over 148 million affected individuals in 2024, projected to exceed 168 million by 2050^[iv]. Suboptimal glycemic control precipitates irreversible microvascular and macrovascular complications, including progressive visual impairment to blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke, and limb amputations^[v]. Diabetes poses a triple threat to global health through its high prevalence, insidious onset, and severe complications. Current therapeutic strategies increasingly prioritize novel anti-diabetic agents that deliver benefits extending beyond glycemic control, including weight loss, cardiovascular risk mitigation, and renal protection^[vi]—essential components for comprehensive diabetes management.

About Mazdutide

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and 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 has been conducted in or completed a total of 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.
• 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.
• 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.

Among these, the first five phase 3 studies have met primary endpoints, and the latter two phase III trials remain ongoing.

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).

*Mazdutide has received NMPA approval for two indications:

1.  Long-term weight control in adult patients
     As an adjunct to dietary control and increased physical activity in adults with initial BMI:

• ≥28 kg/m² (obesity), or
• ≥24 kg/m² (overweight) plus ≥1 weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome).

2.  Glycemic control in adults with T2D:

• Monotherapy:
  Adults with inadequately controlled T2D after diet/exercise intervention alone.

• Combination Therapy:
  Adults with inadequately controlled T2D who insufficient glycemic control despite diet/exercise intervention on metformin and/or sulfonylureas, metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT2i).

Mazdutide has garnered significant academic and industry recognition for its robust clinical data. Clinical results have been presented in globally renowned journals including Nature, NEJM, Nature Communications, Diabetes Care, and eClinicalMedicine. Mazdutide is the first China-developed innovative drug with two clinical studies simultaneously published in Nature and the only GLP-1-based therapy ever to achieve top-tier publications in both Nature and NEJM. It has now been included in multiple Chinese expert consensus guidelines for obesity and type 2 diabetes management. Previously, mazdutide was named to FIERCE Pharma's "Top 10 Most Anticipated Innovative Drugs of 2025", and Its phase 2 clinical trial in Chinese overweight/obese participants was selected by Nature Communications as one of the "50 Most Significant Translational Medicine Studies" and featured as an Editor's Highlight.

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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stages. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Takeda, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

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.

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