The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Start Date21 Oct 2024

Sponsor / Collaborator

Zhongshan Hospital Fudan University

NCT06536023 / RecruitingPhase 1

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects

The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and <18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.

Start Date30 Aug 2024

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20242726 / RecruitingPhase 1

评估IBI362在中国青少年肥胖受试者中多次给药的安全性、耐受性和药代动力学的随机、双盲、安慰剂对照的研究

[Translation] A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of IBI362 after repeated dosing in obese Chinese adolescent subjects

评估IBI362多次腹部皮下注射的安全性和耐受性，并确定其临床使用的安全剂量范围。

[Translation]

To evaluate the safety and tolerability of multiple abdominal subcutaneous injections of IBI362 and determine its safe dose range for clinical use.

Start Date27 Aug 2024

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 Dec 2024·Metabolism

Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials

Article

Author: Xie, Zeyu ; Deng, Weishang ; Cao, Weiling ; Zheng, Guimei ; Li, Mengting ; Liang, Zhuoru

PURPOSEThis study aimed to provide evidence-based support and a reference for the efficacy and safety of seven glucagon-like peptide-1 (GLP-1) receptor agonists and polyagonists for weight loss in patients with obesity or overweight through a network meta-analysis.METHODSRelevant randomized controlled trials (RCTs) with an intervention duration of at least 16 weeks assessing seven GLP-1 receptor agonists and polyagonists (mazdutide, 6 or 4.5 mg; retatrutide, 12 or 8 mg; tirzepatide, 15 or 10 mg; liraglutide, 3.0 mg; semaglutide, 2.4 mg; orforglipron, 45 or 36 mg; and beinaglutide, 0.2 mg) in patient with obesity or overweight was searched using three databases (Cochrane Library, PubMed, and Embase) from creation to August 30, 2024. The primary outcome was the percentage change in body weight from baseline. Secondary outcomes included changes in waist circumference, hemoglobin A1c, and fasting plasma glucose level from baseline; adverse events, serious adverse events, adverse event withdrawal, and hypoglycemic events. We conducted a frequentist random-effects network meta-analysis to analyze the data extracted from the RCTs using Stata 16.1 software.RESULTSTwenty-seven RCTs of seven GLP-1 receptor agonists and polyagonists and 15,584 patients were included in the network meta-analysis. In terms of efficacy, compared with placebo, retatrutide 12 mg (-22.10 % in body weight and - 17.00 cm in waist circumference), retatrutide 8 mg (-20.70 % and - 15.90 cm), and tirzepatide 15 mg (-16.53 % and - 13.23 cm) were the three most efficacious treatments for reducing body weight and waist circumference. However, these treatments were less effective in patients with type 2 diabetes mellitus (T2DM). In addition, patients with a high body mass index (BMI) or longer treatment cycles exhibited significantly greater weight loss than those with a low BMI or shorter treatment cycles. In terms of safety, patients without T2DM had a higher incidence of adverse events than those with T2DM. None of the interventions increased the incidence of serious adverse or hypoglycemic events (˂54 mg/dL). There was no significant difference in the incidence of adverse event withdrawal for all interventions in head-to-head comparisons. In addition, disparities in race, BMI, and treatment cycles did not significantly increase the incidence of adverse events. Finally, the sensitivity and publication bias analyses indicated that the basic analysis results were reliable.CONCLUSIONRetatrutide (both doses) and tirzepatide exhibited superior efficacy compared to other GLP-1 receptor agonists and polyagonists in reducing body weight and waist circumference. Patients without T2DM, those with a high BMI, and individuals undergoing longer treatment cycles demonstrated significantly greater weight loss and reductions in waist circumference. Dual or triple receptor agonists (GLP-1 plus glucose-dependent insulinotropic polypeptide and/or Glucagon receptor) are more effective for weight loss than GLP-1 receptor agonists.

02 May 2024·Expert Opinion on Pharmacotherapy

Oral glucagon-like peptide-1 receptor agonists and combinations of entero-pancreatic hormones as treatments for adults with type 2 diabetes: where are we now?

Review

Author: Melson, Eka ; Papamargaritis, Dimitris ; Davies, Melanie ; Gogineni, Prathima

INTRODUCTIONGlucagon-like peptide-1 (GLP-1) receptor agonists (RAs) have changed the landscape of type 2 diabetes (T2D) management due to their cardio-renal benefits, their glucose-lowering efficacy and weight loss (WL) maintenance. However, the response to GLP-1 RA monotherapy is heterogeneous. Additionally, the majority of GLP-1 RAs are injectable treatments. Oral GLP-1 RAs and injectable combinations of GLP-1 with other entero-pancreatic hormones (glucose-dependent insulinotropic polypeptide (GIP), glucagon and amylin) are under development for T2D and obesity management.AREAS COVEREDHerein, we review the data on (i) oral GLP-1 RAs (oral semaglutide 25/50 mg and orforglipron) and (ii) dual/triple agonists (tirzepatide, cagrilintide 2.4 mg/semaglutide 2.4 mg, survodutide, mazdutide, retatrutide) that have recently completed phase 3 trials for T2D or are currently in phase 3 clinical trials. Tirzepatide is the first approved dual agonist (GLP-1/GIP) for T2D and obesity management.EXPERT OPINIONWe are in a new era in T2D management where entero-pancreatic hormone-based treatments can result in ≥15% WL and euglycemia for many people with T2D. Multiple molecules with different mechanisms of action are under development for T2D, obesity and other metabolic complications. Data on their cardio-renal benefits, long-term efficacy and safety as well as their cost-effectiveness will better inform their position in treatment algorithms.

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

OBJECTIVEWe 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 METHODSAdults 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.RESULTSMean 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]).CONCLUSIONSIn Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reductions.

News (Medical) associated with Mazdutide

19 Sep 2024

·www.pharmaceutical-technology.com

Novo Nordisk and Nanovation sign $600m deal in rare and cardiometabolic diseases

As part of the deal, Novo Nordisk and NanoVation will collaborate on up to seven programmes. Credit: PeopleImages.com – Yuri A via Shutterstock. Novo Nordisk has signed a $600m deal with NanoVation to develop genetic medicines for rare and cardiometabolic diseases. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports NPVM: Innovent Biologics Inc's Mazdutide Reports NPVM: Novo Nordisk AS's Ideal Pump Insulin Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Novo has secured a licence to use NanoVation’s long-circulating lipid nanoparticle (lcLNP) technology for RNA delivery targeting cells outside the liver. Both companies will collaborate on two programmes to develop base-editing therapies for rare genetic diseases, with plans for up to five future targets for cardiometabolic and rare diseases. Under the agreement, Novo is paying an undisclosed upfront fee. The multi-year deal could be worth up to $600m, with NanoVation set to receive research funding eligible for potential milestone payments, as well as tiered royalties on future product sales. Novo has secured several deals in the past few years to maintain its dominant position in the cardiometabolic disease market. The Danish pharma company entered research collaborations with two US cell and gene therapy biotech startups in January, namely Omega Therapeutics and Cellarity. In February 2024, Novo partnered with US-based biotech Neomorph in a collaboration and licensing agreement to discover and develop multiple molecular glue degraders for cardiometabolic disorders and rare diseases. See Also: AstraZeneca’s Fasenra to challenge GSK’s Nucala in rare vasculitis after FDA nod FDA approves Accord BioPharma’s HERCESSI for cancer treatment Novo has also shown its commitment to developing therapies for disorders with unmet needs such as metabolic dysfunction-associated steatohepatitis (MASH). The company’s collaboration with Cellarity involves the development of therapies for MASH, for which there are no treatments approved by the US Food and Drug Administration (FDA). Novo’s Q1 2024 financial results highlighted that the company’s aspiration to expand the use of its blockbuster obesity products to cardiovascular indications has been successful. In March, its obesity drug Wegovy (semaglutide) was approved by the FDA for reducing the risk of cardiovascular diseases in obese or overweight adults. Semaglutide is also marketed as Ozempic in type 2 diabetes. Wegovy generated $4.5bn in sales for Novo in 2023, as per the company’s financials. According to GlobalData analyst consensus forecasts, the drug is set to make $19.4bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the deal, NanoVation’s co-founder Pieter Cullis said: “Genetic medicine is at a pivotal moment and this partnership marks a major milestone for NanoVation as an innovator in nucleic acid delivery. By combining NanoVation’s expertise in extrahepatic delivery with Novo Nordisk’s expertise in cardiometabolic and rare diseases we have the potential to create truly transformative therapies.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

License out/inDrug Approval

12 Sep 2024

·www.prnewswire.com

Head-to-head Superiority over Dulaglutide: Innovent's Phase 3 Clinical Trial DREAMS-2 of Mazdutide in Chinese Patients with Type 2 Diabetes were Orally Presented at EASD 2024

SAN FRANCISCO and SUZHOU, China, Sept. 11, 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 results for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with type 2 diabetes (T2D) (DREAMS-2) were presented as a late-breaking oral presentation (Abstract #: LBA 16) at the 60th Annual Meeting of the European Association for the Study of Diabetes® (EASD). The study results demonstrated the superiority of mazdutide to dulaglutide in both glycemic control and body weight reduction in Chinese participants with T2D. Additionally, mazdutide treatment improved several cardiometabolic risk factors, including blood pressure, lipids, serum uric acid and liver enzymes. Detailed results will be published in peer-reviewed journals. Meanwhile, the first Phase 3 study results of mazdutide in the weight loss of overweight/obese subjects (GLORY-1) were reported in oral presentation session of EASD. Mazdutide also works as a breakthrough weight-loss drug that offers dual-targeted fat burning, liver function improvement, and long-lasting weight reduction, providing comprehensive metabolic benefits to support weight loss and promote a healthier life. DREAMS-2 (ClinicalTrials.gov, NCT05606913) enrolled 731 Chinese participants with T2D (mean age 51.8 years, mean baseline HbA1c 8.22%, mean baseline body weight 76.95 kg), whose diabetes was inadequately controlled with metformin alone or in combination with other oral anti-diabetic medications. Participants were randomized to receive mazdutide 4 mg, mazdutide 6 mg or dulaglutide 1.5 mg for 28 weeks. The primary endpoint was the change in HbA1c from baseline to week 28. Superiority of mazdutide to dulaglutide in glycemic control* For the efficacy estimand, after 28 weeks of treatment, mean reductions in HbA1c from baseline were 1.69% and 1.73% for mazdutide 4 mg and mazdutide 6 mg, respectively, demonstrating superiority over dulaglutide 1.5 mg (1.36%). At week 28, 71.2% and 74.2% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c <7.0% compared to 62.1% with dulaglutide. Additionally, 54.8% and 63.1% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c ≤6.5% , compared to 42.1% for dulaglutide. Mazdutide's superiority over dulaglutide in weight loss and HbA1c/weight composite endpoints * After 28 weeks of treatment, participants treated with mazdutide 4 mg and mazdutide 6 mg experienced mean weight reductions of 9.24% and 7.13%, respectively, significantly outperforming dulaglutide (2.86%). At week 28, 62.4% and 78.2% of participants receiving mazdutide 4 mg and mazdutide 6 mg achieved a weight reduction of ≥5%, compared to 26.9% for dulaglutide. Additionally, 50.1% and 64.3% of participants with mazdutide 4 mg and mazdutide 6 mg achieved both a weight reduction of ≥5% and HbA1c < 7.0%, respectively (dulaglutide 19.4%). Improvements on multiple cardiometabolic risk factors by mazdutide Mazdutide treatment also led to significant and clinically meaningful improvements on fasting glucose, post-prandial glucose, waist circumference, blood pressure, lipids, serum uric acid and transaminases, mostly greater than dulaglutide. Detailed results will be published in peer-reviewed journals. Favorable safety and tolerability profile and no new safety signals Mazdutide was well tolerated, with low incidence of TEAEs leading to treatment discontinuation. The overall safety profile was consistent with previous clinical studies of mazdutide, with no new safety signals observed. Gastrointestinal symptoms were the most common adverse events, mostly mild to moderate in severity, transient, and occurring mainly during dose escalation. No severe hypoglycemia was reported with mazdutide, and the incidence of grade 1-2 hypoglycemia was comparable to dulaglutide. Mazdutide is the first GLP-1R/GCGR dual agonist in the regulatory review status, with a first new drug application (NDA) for chronic weight management and a second NDA for T2D currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Professor Lixin Guo, the principal investigator of the clinical study, Department of Endocrinology in Beijing Hospital, said: "The incidence of type 2 diabetes in China remains high, and a considerable proportion of patients have overweight/obesity, cardiovascular and kidney diseases. In recent years, GLP-1 receptor agonists have offered improved treatment options for patients with type 2 diabetes, providing comprehensive benefits in glucose control, weight management, and cardiovascular and kidney health. As a result, GLP-1-based therapies have become a hot spot and frontier in the development of drugs for metabolic diseases. Mazdutide, one of the fastest-advancing GLP-1R and GCGR dual agonists in clinical development globally, has demonstrated superiority in glucose-lowering and weight-reducing efficacy over dulaglutide in a Phase 3 study of patients with type 2 diabetes. With its additional metabolic benefits and favorable safety profile, mazdutide represents a new generation of GLP-1 therapies for the treatment of type 2 diabetes. I look forward to the clinical availability of mazdutide as soon as possible to provide new treatment options for patients with type 2 diabetes." Dr. Lei Qian, Vice President of Clinical Development of Innovent, said: "China has a large population of people with diabetes, and the task of prevention and treatment is arduous. There is an urgent need for more effective, safer and more convenient innovative drugs. The Phase 3 study results of mazdutide versus dulaglutide reported at EASD were very successful. They showed comprehensive benefits of mazdutide in blood glucose control, weight loss and multiple metabolic indicators. Combined with the results of DREAMS-1, another Phase 3 study of mazdutide as monotherapy in patients with type 2 diabetes, Innovent has submitted an application for the marketing approval of mazdutide for the treatment of type 2 diabetes to the regulatory agency. We look forward to the approval of mazdutide and its potential to benefit a large number of type 2 diabetes patients seeking improvements in glycemic control, weight management and cardiovascular metabolic indicators." About Diabetes According to the 2021 global diabetes overview by the International Diabetes Federation, China leads the world in the number of patients with diabetes, with an estimated 140 million cases in 2021 and projected to reach 174 million by 2045[1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, including reduced visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation[2]. The high prevalence of diabetes and its serious complications pose a significant threat to human health. Currently, various therapeutic approaches are available for diabetes management. In addition to controlling blood glucose, new hypoglycemic drugs are being developed to offer additional benefits such as weight loss, cardiovascular risk reduction and kidney protection[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. Mazdutide has two NDAs accepted by China's NMPA for review, including: For the chronic weight management in adults with obesity or overweight; For the glycemic control in adults with type 2 diabetes. 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 target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory 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 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 , 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: SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultLicense out/inNDA

12 Sep 2024

·www.pharmaceutical-technology.com

EASD 2024: Innovent shows off mazdutide’s efficacy in diabetes and obesity

Mazdutide was developed by Eli Lilly and Innovent acquired the development and commercialisation rights to the therapy in China. Image credit: Alones / Shutterstock. Innovent Biologics has released more data from two Phase III trials evaluating mazdutide in adults with type 2 diabetes (T2D) and obesity. The China-based biotech has presented data from the Phase III GLORY-1 trial (NCT05607680) evaluating the therapy in obese or overweight individuals, along with detailed results from the Phase III DREAMS-2 trial (NCT05606913), which showed mazdutide to be superior to Eli Lilly’s Trulicity (dulaglutide) in managing T2D. The results were presented at the European Association for the Study of Diabetes (EASD) taking place from 9 to 13 September in Madrid, Spain. Mazdutide is a dual agonist of glucagon-like peptide 1 receptor (GLP-1) and human glucagon receptor (GCGR). It was developed by Eli Lilly and Innovent acquired the development and commercialisation rights to the therapy in China. Lilly retains the rights to the drug in all other countries. The Chinese company is currently conducting five Phase III trials evaluating the therapy in Chinese patients with either T2D, obesity or both. The company is also seeking regulatory approval in China for mazdutide in both chronic weight management and glycaemic control in T2D. See Also: Japan approves updated Covid-19 vaccine to tackle JN.1 variant FDA approves Roche’s Tecentriq Hybreza for cancer The EASD presentation was built on data from the randomised placebo-controlled Phase III GLORY-1 trial , which was announced at the American Diabetes Association meeting in June. The trial enrolled 610 Chinese patients who were either overweight or obese. Patients achieved 10.97% and 13.38% reduction in body weight compared to baseline with 4mg and 6mg mazdutide, respectively. At 48 weeks, more than half of patients (50.6%) on high-dose mazdutide reported at least a 15% reduction in body weight. Patients receiving mazdutide also reported an improvement in cardiovascular and kidney functions. Combined analysis of two mazdutide groups showed improvement in systolic blood pressure, triglyceride, cholesterol and low-density lipoprotein (LDL) levels, and a reduction in serum uric acid and alanine aminotransferase levels, compared to placebo. Innovent also presented exploratory data on liver stenosis (fatty liver). The results showed a dose-dependent reduction in liver fat content (LFC). A mean LFC reduction of 7.7% and 13.6% was seen with 4mg and 6mg mazdutide, respectively, compared to 0.8% LFC reduction with placebo. The DREAMS-2 trial evaluated mazdutide as an add-on therapy in 731 Chinese patients with T2D. The therapy was added to the current treatment including metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors and thiazolidinediones. After 28 weeks, patients in mazdutide 4mg and 6mg groups demonstrated a mean reduction in HbA1c 1.69% and 1.73% from baseline, respectively, compared to a 1.36% HbA1c reduction in the Trulicity group. Furthermore, 71.2% and 74.2% of patients receiving mazdutide 4mg and 6mg achieved HbA1c of less than 7%, compared to 62.1% with Trulicity. The company also highlighted the weight reduction seen by these participants. At 28 weeks, 50.1% and 64.3% of participants with mazdutide 4mg and mazdutide 6mg achieved both a weight reduction of at least 5% and HbA1c of less than 7.0%, compared to 19.4% of participants reporting the same with Trulicity. Innovent also teased improvements in cardiometabolic risk factors, including blood pressure, lipids, serum uric acid and transaminases, adding that it plans to publish the detailed results in peer-reviewed journals.

Clinical ResultPhase 3VaccineDrug Approval

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	01 Aug 2024
Obesity	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
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

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GLORY-1 (NEWS) Manual	Phase 3	Overweight \| Obesity	610	Mazdutide	(akqkagsbxk) = hstzmzjjnj cghgrrevvk (rwbbkdavnz ) View more	Positive	13 Sep 2024
				Mazdutide (4 mg)	(ratymnrgrd) = nheashvwag xlocwsmksz (lyjopajtjk ) View more
NCT05606913 (DREAMS-2, EASD2024) Manual	Phase 3	Diabetes Mellitus, Type 2	731	mazdutide 4mg	(yyjegtzcnx) = dcvknakhxd isjhudjksy (gowhwlaleg ) View more	Positive	11 Sep 2024
				mazdutide 6mg	(yyjegtzcnx) = gezbtrcala isjhudjksy (gowhwlaleg ) View more
NCT05623839 (EASD2024) Manual	Phase 1	Overweight \| Obesity	32	Mazdutide (cohort 1)	(pncdhskbqm) = rxndcjtnxy bsunjggkiv (zcqapoyhyw ) View more	Positive	09 Sep 2024
				Mazdutide (cohort 2)	(pncdhskbqm) = udqbblsnoy bsunjggkiv (zcqapoyhyw ) View more
NCT05628311 (DREAMS-1, PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Mazdutide 4 mg	(byfnwrwwaa) = kvcqajdmaj eumibindlz (jtckajqhoo ) Met	Positive	21 Jul 2024
				Mazdutide 6 mg	(byfnwrwwaa) = lpuhhvbqba eumibindlz (jtckajqhoo ) Met
NCT05607680 (GLORY-1, ADA2024) Manual	Phase 3	Overweight \| Obesity	69	Mazdutide 4mg	(hxptqtutpv) = qiphbpkkqd jihgxhloph (kglrdazxzc ) View more	Positive	21 Jun 2024
				Mazdutide 6mg	(hxptqtutpv) = rfhcitgcnh jihgxhloph (kglrdazxzc ) View more
NCT04904913 (ADA2024) Manual	Phase 2	Obesity	80	Mazdutide	(eryemsmomg) = sorjaiusty ijchbwhbci (biqncunhpn ) View more	Positive	20 Jun 2024
				Placebo	(eryemsmomg) = fklhhhobbg ijchbwhbci (biqncunhpn ) View more
NCT05607680 (GLORY-1, ADA2024) Manual	Phase 3	Overweight \| Obesity	610	mazdutide 4 mg	(ojxaccmzsz) = kkovdfalor mrbkftqraz (povsfriolp, 0.538) Met View more	Positive	14 Jun 2024
				mazdutide 6 mg	(ojxaccmzsz) = lvnlxuzekd mrbkftqraz (povsfriolp, 0.558) Met View more
ADA2024	Not Applicable	-	-	Mazdutide 9 mg	eaokbxwmat(wntghutvfu) = most frequently reported adverse events, and most were mild to moderate in severity fymixzdtjt (dqxnwsenvg ) View more	-	14 Jun 2024
				Placebo
NCT05606913 (DREAMS-2, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	731	mazdutide 4.0 mg	(rztcdtkndy) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. mumosxuilz (dnfiuflqup ) 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	(zpyhuxyrsk) = 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 ngrpsesrar (rgwxswfnnn ) Met View more	Positive	09 Jan 2024
				玛仕度肽 6 mg

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