{"id":41961,"date":"2025-12-18T07:00:00","date_gmt":"2025-12-18T00:00:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=41961"},"modified":"2025-12-18T07:00:00","modified_gmt":"2025-12-18T00:00:00","slug":"nature-two-phase-3-clinical-results-of-mazdutide-glp-1-gcg-dual-receptor-agonist-in-chinese-adults-with-type-2-diabetes-have-been-back-to-back-published-in-nature","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=41961","title":{"rendered":"Nature | Two Phase 3 Clinical Results of Mazdutide (GLP-1\/GCG Dual Receptor Agonist) in Chinese Adults with Type 2 Diabetes Have Been Back-to-Back Published in Nature"},"content":{"rendered":"

SAN FRANCISCO<\/span> and SUZHOU, China<\/span><\/span>, Dec. 18, 2025<\/span><\/span> \/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<\/span>) dual receptor agonist, in Chinese adults with type 2 diabetes (T2D) (DREAMS-1, DREAMS-2) have been published back-to-back in Nature<\/i> as Accelerated Article Previews (AAP)\u00a0[<\/span>DREAMS-1<\/span><\/a><\/span>i,<\/sup>DREAMS-2<\/span><\/a><\/span>ii<\/sup>]<\/span>.<\/span><\/span><\/p>\n

The co-first authors of the DREAMS-1 article are Professor Dalong Zhu<\/span> from Nanjing Drum Tower Hospital affiliated with Nanjing University Medical School, and Professor Jiajun Zhao<\/span> 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<\/span> from Beijing Hospital and Professor Bo Zhang<\/span> from China-Japan Friendship Hospital, with Professor Wenying Yang<\/span> from China-Japan Friendship Hospital serving as the corresponding author.<\/p>\n

The Nature<\/i> publication of mazdutide represents multiple historic breakthroughs. It marks the first time that Nature <\/i>has published two Phase 3 clinical studies back-to-back in the field of metabolic and endocrine diseases, and mazdutide became the first China<\/span>-developed drug to have two studies published simultaneously in Nature<\/i>. Notably, mazdutide’s first Phase 3 weight loss clinical study (GLORY-1) were published in The New England Journal of Medicine<\/i>, making it the only GLP-1<\/span> therapy to reach the top journals of both Nature<\/i> and NEJM<\/i>. This achievement signifies the highest level of international academic recognition for China’s<\/span> 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<\/span>-leading innovative pharmaceutical company, have made a significant contribution to China’s<\/span> “Weight Management Year” and “Healthy China” strategy, one that demonstrates both substantial clinical value and international impact.<\/b><\/p>\n

This publication as Accelerated Article Preview (AAP) in Nature<\/i> 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.<\/p>\n

Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics<\/b>, stated, “Mazdutide is the world’s first approved GCG\/GLP-1<\/span> 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) <\/i>this May, our landmark findings from the DREAMS-1 and DREAMS-2 trials have now been published back-to-back in Nature<\/i> as Accelerated Article Previews (AAP). This represents a pivotal milestone for China’s<\/span> 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<\/span> leading biopharmaceutical innovators. These pivotal findings are expected to inform global clinical guidelines and practice. With mazdutide now approved in China<\/span> 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’.”<\/p>\n

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

The two Phase 3 studies published in Nature<\/i> 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.<\/b><\/p>\n

In DREAMS-1, 320 Chinese adults with T2D inadequately controlled with diet and exercise alone (mean age 50.4 years; baseline HbA1c<\/sub> 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 HbA1c<\/sub> at Week 24.<\/p>\n

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 HbA1c<\/sub> 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 HbA1c<\/sub> at Week 28.<\/p>\n

Mazdutide achieves clinically significant 2.02% HbA1c<\/sub> reduction at Week 24<\/b><\/p>\n

In the DREAMS-1 trial, under the treatment-policy estimand analysis, the adjusted least-squares (LS) mean changes in HbA1c<\/sub> 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 HbA1c<\/sub> <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.<\/p>\n

In the DREAMS-2 trial, under the treatment-policy estimand analysis, the adjusted LS mean changes in HbA1c<\/sub> 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 HbA1c<\/sub> <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.<\/p>\n

Mazdutide demonstrated dual superiority in both glycemic control and weight loss versus comparators<\/b><\/p>\n

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 \u22655% weight loss were 48.8%, 64.0%, and 6.6%, respectively, with 39.0%, 58.5%, and 0% achieving both HbA1c<\/sub> <7% and \u22655% weight loss. These outcomes were consistent with the efficacy estimand analyses.<\/p>\n

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 \u22655% weight loss were 58.6%, 73.1%, and 26.6%, respectively, with 46.9%, 59.9%, and 18.9% achieving both HbA1c<\/sub> <7% and \u22655% weight loss. These outcomes were consistent with the efficacy estimand analyses.<\/p>\n

Mazdutide demonstrated multiple cardiometabolic benefits <\/b><\/p>\n

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\u2014particularly beneficial for the Chinese population, who are more prone to visceral fat accumulation.<\/p>\n

Mazdutide demonstrated a favorable safety profile\u00a0<\/b>consistent with prior findings<\/b><\/p>\n

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\u20122) hypoglycemia similar to dulaglutide 1.5 mg.<\/p>\n

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<\/span> 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\u2014at Week 32, the proportion of participants achieving HbA1c<\/sub> < 7.0% and \u226510% body weight reduction from baseline at week 32 (48.0 vs. 21.0%, p<0.0001).<\/p>\n

About diabetes <\/b><\/p>\n

China<\/span> 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]<\/sup>. 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]<\/sup>. 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]<\/sup>\u2014essential components for comprehensive diabetes management.<\/p>\n

About Mazdutide <\/b><\/p>\n

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<\/span>. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1<\/span> receptor agonists\u2014such as promoting insulin secretion, lowering blood glucose and reducing body weight\u2014by 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.<\/p>\n

Mazdutide has been conducted in or completed a total of seven Phase 3 clinical studies, including:<\/p>\n