A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)

This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 40-week double-blind treatment period, and a 4-week drug withdrawal safety follow-up period

Start Date29 Feb 2024

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20234187 / RecruitingPhase 3

一项在经单纯饮食运动干预伴/不伴二甲双胍单药治疗血糖、体重控制不佳的中国早期2 型糖尿病合并肥胖受试者中评估IBI362 和司美格鲁肽的疗效和安全性的多中心、随机、开放标签临床研究

[Translation] A multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of IBI362 and semaglutide in Chinese obese subjects with early type 2 diabetes who have poor blood sugar and weight control after simple diet and exercise intervention with or without metformin monotherapy

验证IBI362第32周的降糖和减重的复合疗效优于司美格鲁肽

[Translation]

Verify that the combined efficacy of IBI362 in reducing blood sugar and weight at week 32 is superior to that of semaglutide

Start Date26 Feb 2024

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

[+2]

NCT06164873 / RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Start Date27 Dec 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Mazdutide

100 Translational Medicine associated with Mazdutide

100 Patents (Medical) associated with Mazdutide

Literatures (Medical) associated with Mazdutide

01 Jan 2024·Diabetes care

Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Article

Author: Wang, Xiaoyun ; Cheng, Zhifeng ; Jin, Ping ; Qian, Lei ; Ye, Shandong ; Yang, Wenying ; Gu, Xuejiang ; Zhang, Xin ; Gan, Shenglian ; Ma, Jianhua ; Deng, Huan ; Wang, Guixia ; Shi, Bimin ; Sun, Juan ; Li, Haoyu ; Ma, Guoqing ; Li, Li ; Ma, Qingyang ; Liu, Dexue ; Ji, Linong ; An, Pei ; Zhang, Bo ; Yu, Ting ; Jiang, Hongwei ; Chen, Ji ; Yi, Jianjun

OBJECTIVE:

We conducted a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the efficacy and safety of mazdutide, a once-weekly glucagon-like peptide 1 and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS:

Adults with type 2 diabetes inadequately controlled with diet and exercise alone or with stable metformin (glycated hemoglobin A1c [HbA1c] 7.0–10.5% [53–91 mmol/mol]) were randomly assigned to receive 3 mg mazdutide (n = 51), 4.5 mg mazdutide (n = 49), 6 mg mazdutide (n = 49), 1.5 mg open-label dulaglutide (n = 50), or placebo (n = 51) subcutaneously for 20 weeks. The primary outcome was change in HbA1c from baseline to week 20.

RESULTS:

Mean changes in HbA1c from baseline to week 20 ranged from −1.41% to −1.67% with mazdutide (−1.35% with dulaglutide and 0.03% with placebo; all P < 0.0001 vs. placebo). Mean percent changes in body weight from baseline to week 20 were dose dependent and up to −7.1% with mazdutide (−2.7% with dulaglutide and −1.4% with placebo). At week 20, participants receiving mazdutide were more likely to achieve HbA1c targets of <7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol) and body weight loss from baseline of ≥5% and ≥10% compared with placebo-treated participants. The most common adverse events with mazdutide included diarrhea (36%), decreased appetite (29%), nausea (23%), vomiting (14%), and hypoglycemia (10% [8% with placebo]).

CONCLUSIONS:

In Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reductions.

01 Dec 2022·EClinicalMedicine

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial

Article

Author: Deng, Huan ; Wen, Jie ; Jiang, Hongwei ; Gao, Leili ; Feng, Liqi ; Yu, Lei ; Song, Baili ; Ma, Qingyang ; Ji, Linong ; Cai, Chenghang ; Qian, Lei ; Yang, Jing

Background:

Mazdutide (also known as IBI362 or LY3305677), a novel once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, achieved 12-week body weight loss up to 6.4% at doses up to 6 mg in Chinese adults with overweight or obesity. We further explored the safety and efficacy of mazdutide dosed up to 9 mg and 10 mg.

Methods:

In this randomised, placebo-controlled, multiple-ascending-dose phase 1b trial, we enrolled adults (aged 18-75 years, both inclusive) with overweight (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m²) from five hospitals in China. Eligible participants were randomly assigned (2:1) within each cohort by using an interactive web-response system to receive once-weekly subcutaneous mazdutide or placebo for 12 weeks in the 9 mg cohort (3 mg weeks 1-4; 6 mg weeks 5-8; 9 mg weeks 9-12) and for 16 weeks in the 10 mg cohort (2.5 mg weeks 1-4; 5 mg weeks 5-8; 7.5 mg weeks 9-12; 10 mg weeks 13-16). The participants, investigators, study site personnel involved in treating and assessing participants in each cohort and sponsor personnel were masked to treatment allocation. The primary outcomes were safety and tolerability of mazdutide, assessed from baseline to end of follow-up in all participants who received at least one dose of the study treatment. The secondary outcomes included the change from baseline to week 12 or week 16 in body weight, waist circumference and BMI. This trial is registered with ClinicalTrials.gov, NCT04440345.

Findings:

Between Mar. 1, 2021 and Mar. 26, 2021, a total of 24 participants were enrolled, with eight randomly assigned to mazdutide and four to placebo in each cohort. One participant receiving mazdutide and two receiving placebo in the 10 mg cohort withdrew consent and quitted the study. No serious adverse event was reported. All treatment-emergent adverse events (TEAEs) were mild or moderate in severity and most commonly-reported TEAEs were upper respiratory tract infection, diarrhoea, decreased appetite, nausea, urinary tract infection, abdominal distension and vomiting. The mean percent change from baseline to week 12 in body weight were -11.7% (SE 1.5) for participants receiving mazdutide in the 9 mg cohort and -1.8% (1.6) for participants receiving placebo (estimated treatment difference [ETD]: -9.8%; 95% confidence interval [CI]: -14.4, -5.3; P = 0.0002). The mean percent change from baseline to week 16 in body weight were -9.5% (SE 1.7) for participants receiving mazdutide in the 10 mg cohort and -3.3% (1.9) for participants receiving placebo (ETD: -6.2%; 95% CI: -11.5, -0.9; P = 0.024). In addition, compared with placebo, mazdutide achieved more profound reductions in waist circumference and BMI.

Interpretation:

Mazdutide dosed up to 9 mg and 10 mg was both well tolerated and showed a favourable safety profile. High-dose mazdutide showed promising 12-week body weight loss, holding great potential for the treatment of moderate-to-severe obesity. A larger and longer phase 2 trial will further evaluate the efficacy and safety of high-dose mazdutide in Chinese adults with obesity.

Funding:

Innovent Biologics, Inc.

01 Sep 2021·EClinicalMedicine

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study

Article

Author: Qian, Lei ; Han-Zhang, Han ; Song, Baili ; Jiang, Hongwei ; Feng, Liqi ; An, Pei ; Deng, Huan ; Ma, Qingyang ; Li, Li ; Liu, Meng ; Ji, Linong

BACKGROUND:

IBI362 (LY3305677) is a novel weekly-dose glucagon-like peptide-1 and glucagon receptor dual agonist being developed for the treatment of obesity and type 2 diabetes. The aim of this randomised, placebo-controlled, multiple ascending dose phase 1b study was to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI362 in Chinese adults with overweight or obesity.

METHODS:

This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m²) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m²) from six study centres in China. Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up. The dose-escalation regimens were: 3.0 mg cohort (1.0 mg weeks 1-4; 2.0 mg weeks 5-8; 3.0 mg weeks 9-12); 4.5 mg cohort (1.5 mg weeks 1-4; 3.0 mg weeks 5-8; 4.5 mg weeks 9-12); 6.0 mg cohort (2.0 mg weeks 1-4; 4.0 mg weeks 5-8; 6.0 mg weeks 9-12). The participants, investigators and study site personnel involved in treating and assessing participants within each cohort were masked to treatment allocation. The primary endpoints were safety and tolerability of IBI362. This study is registered with ClinicalTrials.gov, number NCT04440345.

FINDINGS:

Between June 15^th, 2020 and January 15^th, 2021, 12 participants were enrolled and randomised in each cohort. Throughout the study, no participant discontinued the treatment due to safety reason and no serious adverse event was reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events and mostly mild in severity. Three participants receiving IBI362 reported mild and asymptomatic cardiac disorders revealed by electrocardiogram. Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.

INTERPRETATION:

IBI362 was well tolerated and showed a body weight-lowering effect in Chinese adults with overweight or obesity.

FUNDING:

Innovent Biologics.

News (Medical) associated with Mazdutide

22 Jul 2024

·www.fiercebiotech.com

Innovent bags another phase 3 win in China for next-gen Lilly GLP-1 drug

Lilly is developing the dual agonist in other parts of the world. Innovent has pulled off another late-phase win for its Eli Lilly-partnered GLP-1 drug candidate, linking the dual agonist to improved outcomes in type 2 diabetes to tee up a filing for approval in China. Lilly granted Innovent rights to the dual GLP-1/glucagon receptor agonist mazdutide in China in 2019. At Lilly, the molecule, which is also called LY3305677, has played second fiddle to tirzepatide—the GLP-1 receptor agonist sold as Mounjaro and Zepbound. As tirzepatide emerged as the star of Lilly’s portfolio, the Big Pharma weighed up whether mazdutide represented a meaningful improvement. Innovent plowed ahead as Lilly mulled its options, reporting phase 3 data in adults with overweight or obesity in January and having a Chinese application for approval in weight management accepted weeks later. The latest update puts Innovent on course to seek approval in China in type 2 diabetes. The study randomized 320 Chinese adults with type 2 diabetes and insufficient glycemic control using diet and exercise alone to take one of two doses of mazdutide or placebo once a week. After 24 weeks, HbA1c, a measure of blood sugar, had fallen by 1.57% and 2.15%, respectively, in the low and high dose mazdutide cohorts. HbA1c fell by 0.14% in the placebo arm. The HbA1c data caused the study to hit its primary endpoint. Innovent said the reduction in HbA1c while on mazdutide was sustained through week 48. The Chinese drugmaker also reported significant weight loss, with patients shedding 9.6% after 48 weeks on the high dose, and improvements in measures such as waist circumference and blood pressure. While cross-trial comparisons can be misleading, the study suggests mazdutide is competitive without providing conclusive evidence that it is an improvement over Lilly’s tirzepatide in type 2 diabetes. Lilly reported a 2.07% reduction in HbA1c after 40 weeks of treatment with the high dose of tirzepatide. HbA1c was higher at baseline in the mazdutide trial, 8.24%, than the tirzepatide study, 7.9%. The two molecules could compete for market share in China. Lilly won Chinese approval for tirzepatide in diabetes in May and added authorization in weight management late last week. Novo Nordisk previously won approval for semaglutide, the GLP-1 medicine it sells as Ozempic and Wegovy, in both indications in China. While potentially competing with mazdutide in China, Lilly is developing the dual agonist in other parts of the world. The Big Pharma began a phase 2 study in adults with overweight or obesity in the U.S. in November. But diabetes isn’t currently an area of active study, with Lilly wrapping up a phase 1 trial in the indication in 2021.

Phase 2Phase 3Drug ApprovalClinical ResultPhase 1

22 Jul 2024

·firstwordpharma.com

Second Phase III win sets stage for Chinese approval of Innovent’s mazdutide in diabetes

Innovent Biologics on Monday said its dual GLP-1/glucagon receptor (GCGR) agonist mazdutide met the primary and key secondary endpoints of a second Phase III study, dubbed DREAMS-1, in Chinese patients with type 2 diabetes. The success comes after the DREAMS-2 study demonstrated mazdutide’s superiority over Eli Lilly’s GLP-1 receptor agonist Trulicity (dulaglutide) in May.Backed by data from DREAMS-1 and DREAMS-2, Innovent intends to file a marketing application for mazdutide with China's National Medical Products Administration (NMPA) in the near term. Touting the drug as “the first and fastest-developed GLP-1R/GCGR dual agonist in the world,” Lei Qian, vice president of clinical development at Innovent, said “the two studies demonstrate mazdutide's comprehensive efficacy in improving glycaemic control, promoting weight loss, and enhancing metabolic outcomes in patients with [type 2 diabetes].” Marked HbA1C reductionDREAMS-1 randomised 320 participants with type 2 diabetes, inadequately controlled on diet and exercise alone, to receive either mazdutide 4 mg, 6 mg or placebo for 24 weeks. Results showed that both doses of Innovent’s therapy demonstrated superiority to placebo on the main goal of change in HbA1c level from baseline at 24 weeks (1.57% and 2.15% vs 0.14%, respectively). Moreover, mazdutide beat placebo on secondary endpoints of glucose-lowering and weight loss, alongside cardiometabolic indicators such as waist circumference, blood pressure, blood lipids, liver transaminases and urine albumin-to-creatinine ratio. In terms of safety, the company noted a low incidence of hypoglycaemia events in the study, none being severe. Innovent, which secured Chinese rights to mazdutide from Eli Lilly in 2019, is also conducting the Phase III DREAMS-3 trial pitting the drug head-on with Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide). Lilly has already positioned Mounjaro (tirzepatide) in the Chinese market, after having gained approval recently. Meanwhile, a regulatory review of mazdutide for chronic weight management in adults with obesity or overweight is under way in China following its success in the GLORY-1 study.

Phase 3Clinical ResultDrug Approval

22 Jul 2024

·www.prnewswire.com

Innovent Announces the Second Phase 3 Trial of Mazdutide in Chinese Patients with Type 2 Diabetes Met Study Endpoints, and Plans to Submit NDA of Mazdutide to the NMPA

SAN FRANCISCO and SUZHOU, China, July 21, 2024 /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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical trial (DREAMS-1) of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with type 2 diabetes (T2D) met the primary endpoint and all key secondary endpoints. Another Phase 3 clinical trial DREAMS-2 has previously met the study endpoints, in which mazdutide showed superiority compared with dulaglutide for glycaemic control, as well as weight loss and multiple cardiometabolic benefits in T2D patients. Innovent plans to submit a new drug application (NDA) of mazdutide for T2D treatment to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term, following the acceptance of its first NDA for chronic weight management in February 2024. DREAMS-1 (NCT05628311) is a randomized, double-blind, placebo-controlled, Phase 3 clinical trial designed to evaluate the efficacy and safety of mazdutide in Chinese adults with T2D and insufficient glycemic control using diet and exercise alone. A total of 320 participants were enrolled in the study (mean HbA1c and body weight at baseline were 8.24% and 77.7 kg, respectively) and randomized in a 1: 1: 1 ratio to receive either mazdutide 4 mg, mazdutide 6 mg or placebo for 24 weeks in the double-blind period; after completing the double-blind treatment period, participants in the 4 mg and 6 mg groups maintained receiving treatment, while those in the placebo group were switched to receive mazdutide 6 mg for 24 weeks. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) at week 24; a superiority design was used to test the superiority of each dose group of mazdutide versus placebo for the primary endpoint and key secondary endpoints. The primary endpoint was successfully met, showing a robust glucose-lowering efficacy of mazdutide At week 24, the reduction from baseline in HbA1c in both the mazdutide 4 mg (1.57%) and 6 mg groups (2.15%) was superior to the placebo (0.14%; both p-values < 0.0001). The efficacy of HbA1c reduction in patients treated with mazdutide was sustained through week 48. Key secondary endpoints suggest dual advantages of mazdutide in glucose-lowering and weight-reduction At week 24, mazdutide showed significantly higher weight reduction compared with placebo. The proportion of patients who achieved HbA1c<7.0%, weight reduction≥5%, and dual targets of HbA1c<7% and weight reduction≥5% were significantly higher in mazdutide groups than placebo. At week 48, patients treated with mazdutide 6mg showed weight loss of 9.6% from baseline. Mazdutide brought multiple benefits for patients with T2D Besides HbA1c and weight loss, mazdutide also reduced cardiovascular metabolic indicators including postprandial blood glucose, waist circumference, blood pressure, blood lipids, transaminases, and urinary albumin-to-creatinine ratio. Favorable safety and tolerability profile with no additional safety signals Overall safety and tolerability were favorable and consistent with previous clinical studies of mazdutide. The most commonly reported adverse events were gastrointestinal adverse events, mostly mild to moderate. No new safety signals were identified. The incidence of hypoglycemia events was low, most of which were Grade 1 hypoglycemia (3.0 mmol/L ≤ blood glucose < 3.9 mmol/L). No severe hypoglycemia events were reported. Professor Dalong Zhu, the leading principal investigator of the study, Affiliated Drum Tower Hospital, Medical School of Nanjing University, stated, "Patients with T2D often have multiple chronic conditions, including obesity, hyperlipidemia, coronary heart disease, hypertension, etc. Effective disease management should encompass the control of blood glucose, blood lipid, blood pressure and other aspects. The multifaceted benefits of multi-target GLP-1 drugs have garnered significant interest from both the research and clinical communities. As a novel GLP-1R/GCGR dual-target agonist, mazdutide not only demonstrated significant glucose-lowering effects in DREAMS-1 study, but also provided a range of comprehensive benefits including reduction in body weight, blood lipids, blood pressure, liver enzymes, etc., while maintaining favorable safety and tolerability. I hope that mazdutide will be marketed as soon as possible to help Chinese T2D patients achieve target blood glucose levels multiple metabolic benefits." Professor Jiajun Zhao, the leading principal investigator of the study, Shandong Provincial Hospital, stated, "China has the highest prevalence of diabetes globally with more than 140 million people living with diabetes. The number continues to rise annually, presenting a challenge in disease prevention and management. There is an urgent need for innovative medications that offer enhanced efficacy and comprehensive benefits. In the treatment of Chinese patients with T2D, mazdutide showed excellent glucose-lowering effects and multiple metabolic benefits. Under long-term treatment, its efficacy, safety and tolerability remained consistently stable. The results of DREAMS-1 provide significant medical evidence supporting the use of next-generation multi-target GLP-1R/GCGR drugs for treating T2D. I believe mazdutide will offer a superior therapeutic option for Chinese patients with T2D in future." Dr Lei Qian, Vice President of Clinical Development of Innovent, stated, "Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications. The results of DREAMS-1 provided high-quality, compelling evidence for T2D treatment in China, particularly in previously untreated patients whose blood glucose was inadequately controlled with diet and exercise alone. The results of another Phase 3 study DREAMS-2, involving patients with T2D inadequately controlled by oral antidiabetic drugs (OADs), met the study endpoints in May 2024. Together, the two studies demonstrate mazdutide's comprehensive efficacy in improving glycemic control, promoting weight loss, and enhancing metabolic outcomes in patients with T2D. Detailed data will be published at academic congresses or academic journals. Meanwhile, we look forward to the performance of mazdutide in the DREAMS-3 study, a head-to-head study with semaglutide." About Diabetes According to the global overview of diabetes published by the International Diabetes Federation in 2021, China ranks first in number of patients with diabetes globally, with an estimated number of more than 140 million in 2021 and 174 million in 2045[1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, such as decreased visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation[2]. The high prevalence of diabetes, along with its serious complications, poses a significant threat to human health. At present, there are many therapeutic regimens for diabetes. In addition to effectively controlling blood glucose, the development of new hypoglycemic drugs has begun to include the additional benefits of weight loss, cardiovascular risk reduction and kidney protection for patients with diabetes[3]. 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 promotes insulin secretion, lowers blood glucose and reduces body weight similar to GLP-1 receptor agonists. Additionally, it may increase energy expenditure and improve hepatic fat metabolism by activating the glucagon receptor. Mazdutide has strong efficacy in weight loss and lowering glucose levels in clinical studies. It also offers multiple cardio-metabolic benefits, such as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, while improving insulin sensitivity. In February 2024, the first NDA of mazdutide was accepted by the CDE of China's NMPA for chronic weight management in adults with obesity or overweight. Currently, a total of five Phase 3 studies of mazdutide are underway, including: Phase 3 study conducted in Chinese adults with overweight or obesity (GLORY-1); Phase 3 study conducted in Chinese adults with moderate to severe obesity (GLORY-2); Phase 3 study in newly treated Chinese patients with type 2 diabetes (DREAMS-1); Phase 3 study comparing mazdutide and dulaglutide in Chinese patients with type 2 diabetes (DREAMS-2); Phase 3 study comparing mazdutide and semaglutide in Chinese patients with type 2 diabetes and obesity (DREAMS-3). Among them, GLORY-1, DREAMS-1 and DREAMS-2 have reached the study endpoints. 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 treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 4 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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 , 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 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: Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projects for 2045 [published correction appeals in Diabetes Res Clin Pract. 2023 Oct; 204: 110945]. Diabetes Res Clin Pract. 2022; 183: 109119. doi: 10.1016/j.diabres.2021. 109119 Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. Published online 2016. doi: 10.1016/S2213-8587 (16) 30010-9 Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes-state-of-the-art. Mol Metab. Published online 2020. doi: 10.1016/j.molmet.2020. 101102 SOURCE Innovent Biologics

Phase 3Clinical ResultLicense out/inNDA

100 Deals associated with Mazdutide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	07 Feb 2024
Overweight	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	07 Feb 2024
Early-onset type II diabetes	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	29 Feb 2024
Diabetes Mellitus, Type 2	Phase 3	CN	Innovent Biologics (HK) Ltd.	20 Nov 2022
Renal Insufficiency	Phase 1	CN	Innovent Biologics (HK) Ltd.	05 May 2023
Nonalcoholic Steatohepatitis	IND Approval	CN	Innovent Biologics (Suzhou) Co. Ltd.	22 Mar 2023
Hyperuricemia	Preclinical	CN	Innovent Biologics (Suzhou) Co. Ltd.	12 Jul 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05628311 (DREAMS-1, PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Mazdutide 4 mg	qoppzrywvg(asbsqzqsjx) = jtnwhqjkhd evjirytblp (clmipxrnis ) Met	Positive	21 Jul 2024
				Mazdutide 6 mg	qoppzrywvg(asbsqzqsjx) = vcmgacjqpr evjirytblp (clmipxrnis ) Met
NCT05607680 (GLORY-1, ADA2024) Manual	Phase 3	Overweight \| Obesity	69	Mazdutide 4mg	lferauaugy(fqxushzhuz) = zlaoztjing qblpmexnqn (rbjcomzsbp ) View more	Positive	21 Jun 2024
				Mazdutide 6mg	lferauaugy(fqxushzhuz) = fbxcovlozt qblpmexnqn (rbjcomzsbp ) View more
NCT04904913 (ADA2024) Manual	Phase 2	Obesity	80	Mazdutide	kzgbgawvdx(uogvsjrsfy) = wpvnpjjwvq rscrwabove (vbhpfvxeoc ) View more	Positive	20 Jun 2024
				Placebo	kzgbgawvdx(uogvsjrsfy) = sbpgtlzfze rscrwabove (vbhpfvxeoc ) View more
NCT05607680 (GLORY-1, ADA2024) Manual	Phase 3	Overweight \| Obesity	610	mazdutide 4 mg	xybfkrhfjb(qustfulcpt) = odqffxcbpa gajrljhbac (qpsobeewuq, 0.538) Met View more	Positive	14 Jun 2024
				mazdutide 6 mg	xybfkrhfjb(qustfulcpt) = muwiqilesn gajrljhbac (qpsobeewuq, 0.558) Met View more
NCT05606913 (DREAMS-2, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	731	mazdutide 4.0 mg	dhwrgbvzsa(mlvuprfnxk) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. fjrvvkjrti (ztjtvbujjk ) Met View more	Superior	09 May 2024
				mazdutide 6.0 mg
NCT05607680 (GLORY-1, Corporate Publications) Manual	Phase 3	Overweight \| Obesity	610	玛仕度肽 4 mg	aethniqitn(kowcojefvp) = 主要研究终点顺利达成：玛仕度肽 4 mg和6 mg组受试者治疗32周后体重相对基线的百分比变化显著优于安慰剂组 llyftiourc (fmfbohxlyc ) Met View more	Positive	09 Jan 2024
				玛仕度肽 6 mg
NCT04904913 (Literature) Manual	Phase 2	Overweight \| Obesity	248	mazdutide 3 mg	couaabhgop(imlmkujbag) = jsjeolkwqe isvplqdjnw (aykdymszcg, 0.7) View more	Positive	14 Dec 2023
				mazdutide 4.5 mg	couaabhgop(imlmkujbag) = ebozmmfiqz isvplqdjnw (aykdymszcg, 0.7) View more
NCT04965506 (Literature) Manual	Phase 2	Diabetes Mellitus, Type 2	250	Mazdutide 3 mg	efxmelbimt(mtmizjdmzr) = rrfxbnizix bivgjzqbnf (fdgiqqilvc ) View more	Positive	09 Nov 2023
				Mazdutide 4.5 mg	efxmelbimt(mtmizjdmzr) = uixisljjag bivgjzqbnf (fdgiqqilvc ) View more
NCT04904913 (PRNewswire) Manual	Phase 2	Obesity	80	Mazdutide 9 mg	apmblwwoke(mittuhzcns): Difference(%) = -15.4 Met View more	Positive	30 Oct 2023
				placebo
NCT04904913 (Corporate Publications) Manual	Phase 2	Obesity	80	IBI362 9 mg	qudcshabce(gmphqrgnsh): difference = -15.4% (95% CI, -18.8 to -11.9), P-Value = <0.0001 Met View more	Positive	11 May 2023
				placebo

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