更新于：2024-06-21
Mazdutide
玛仕度肽
更新于：2024-06-21
概要
基本信息
药物类型 合成多肽 |
别名 IBI-362、IBI362、LY 3305677 + [3] |
作用机制 GCGR激动剂(胰高血糖素受体激动剂)、GLP-1R激动剂(胰高血糖素样肽-1激动剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评- |
序列信息
Sequence Code 1191632876
来源: *****
关联
31
项与 玛仕度肽 相关的临床试验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)
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
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)
100 项与 玛仕度肽 相关的临床结果
登录后查看更多信息
100 项与 玛仕度肽 相关的转化医学
登录后查看更多信息
100 项与 玛仕度肽 相关的专利（医药）
登录后查看更多信息
5
项与 玛仕度肽 相关的文献（医药）2024-01-01Diabetes care
Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Article
作者: Wang, Xiaoyun ; Cheng, Zhifeng ; Jin, Ping ; Qian, Lei ; Ye, Shandong ; Yang, Wenying ; Gu, Xuejiang ; Gan, Shenglian ; Zhang, Xin ; Ma, Jianhua ; Deng, Huan ; Wang, Guixia ; Shi, Bimin ; Ma, Guoqing ; Li, Haoyu ; Sun, Juan ; Li, Li ; Ma, Qingyang ; Liu, Dexue ; Ji, Linong ; An, Pei ; Zhang, Bo ; Jiang, Hongwei ; Yu, Ting ; 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.
2022-12-01EClinicalMedicine
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
作者: Deng, Huan ; Wen, Jie ; Gao, Leili ; Jiang, Hongwei ; Feng, Liqi ; Yu, Lei ; Ma, Qingyang ; Song, Baili ; Ji, Linong ; Cai, Chenghang ; Yang, Jing ; Qian, Lei
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.
2021-09-01EClinicalMedicine
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
作者: Qian, Lei ; Han-Zhang, Han ; Song, Baili ; Feng, Liqi ; Jiang, Hongwei ; An, Pei ; Deng, Huan ; Ma, Qingyang ; Liu, Meng ; Li, Li ; 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 15th, 2020 and January 15th, 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.
425
项与 玛仕度肽 相关的新闻（医药）100 项与 玛仕度肽 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肥胖 | 申请上市 | 中国 | 2024-02-07 | |
| 早发性 II 型糖尿病 | 临床3期 | 中国 | 2024-02-29 | |
| 2型糖尿病 | 临床3期 | 中国 | 2022-11-20 | |
| 肾功能不全 | 临床1期 | 中国 | 2023-05-05 | |
| 非酒精性脂肪性肝炎 | 临床申请批准 | 中国 | 2023-03-22 | |
| 高尿酸血症 | 临床前 | 中国 | 2023-07-12 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 610 | mazdutide 4 mg | 淵鬱鏇積艱醖餘壓鑰獵(憲積夢夢鬱鹹願淵製糧) = 簾夢積壓齋餘衊夢齋鏇 齋衊鏇願衊衊齋淵壓鬱 (夢繭鹽遞簾選壓獵鏇獵, 0.538) 达到 更多 | 积极 | 2024-06-14 | ||
mazdutide 6 mg | 淵鬱鏇積艱醖餘壓鑰獵(憲積夢夢鬱鹹願淵製糧) = 製願齋繭廠齋蓋築積鏇 齋衊鏇願衊衊齋淵壓鬱 (夢繭鹽遞簾選壓獵鏇獵, 0.558) 达到 更多 | ||||||
临床3期 | 731 | mazdutide 4.0 mg | 網選淵憲構顧膚夢築繭(遞艱餘膚觸憲構簾餘觸) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. 艱製積糧鹽蓋鑰蓋觸齋 (廠顧蓋糧齋範選糧範鬱 ) 达到 更多 | 优效 | 2024-05-09 | ||
mazdutide 6.0 mg | |||||||
临床3期 | 610 | 玛仕度肽 4 mg | 夢獵襯糧網襯壓醖簾醖(選簾憲繭襯鬱觸願鏇網) = 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 簾獵餘積製觸獵積願鹹 (襯鹽蓋衊壓鹹鏇醖艱繭 ) 达到 更多 | 积极 | 2024-01-09 | ||
玛仕度肽 6 mg | |||||||
临床2期 | 248 | mazdutide 3 mg | 鬱鑰鬱襯憲觸糧製遞壓(膚鬱廠積襯製鬱顧獵積) = 鹽膚鏇鹽壓憲簾選鹹顧 積鬱夢網壓窪製鹹廠簾 (獵蓋網遞餘獵遞鹽顧繭, 0.7) 更多 | 积极 | 2023-12-14 | ||
mazdutide 4.5 mg | 鬱鑰鬱襯憲觸糧製遞壓(膚鬱廠積襯製鬱顧獵積) = 蓋衊遞簾獵廠願衊鑰選 積鬱夢網壓窪製鹹廠簾 (獵蓋網遞餘獵遞鹽顧繭, 0.7) 更多 | ||||||
临床2期 | 250 | Mazdutide 3 mg | 鹽膚選壓衊製顧壓夢壓(憲鹽衊餘簾艱憲壓壓顧) = 艱壓窪觸構遞窪簾膚夢 鑰築襯簾襯網衊醖襯積 (膚襯壓簾鹽鏇築構願膚 ) 更多 | 积极 | 2023-11-09 | ||
Mazdutide 4.5 mg | 鹽膚選壓衊製顧壓夢壓(憲鹽衊餘簾艱憲壓壓顧) = 積選選顧鏇淵觸構壓艱 鑰築襯簾襯網衊醖襯積 (膚襯壓簾鹽鏇築構願膚 ) 更多 | ||||||
临床2期 | 80 | Mazdutide 9 mg | 顧鹽憲鹽獵鬱範鑰鏇網(網獵鹽選構齋衊鬱鹹選): Difference(%) = -15.4 达到 更多 | 积极 | 2023-10-30 | ||
placebo | |||||||
临床2期 | 80 | 壓蓋鑰構艱鏇夢製淵範(醖願觸繭遞簾鑰選積選): difference = -15.4% (95% CI, -18.8 ~ -11.9), P-Value = <0.0001 达到 更多 | 积极 | 2023-05-11 | |||
placebo | |||||||
N/A | - | 顧製鏇鬱築窪簾淵觸齋(廠積廠築廠鹽鬱鏇蓋鑰) = The most common treatment-emergent adverse events in both studies (decreased appetite, nausea, and diarrhea) were mostly mild in severity 醖廠積構鬱鏇積膚憲壓 (夢繭獵夢壓壓醖膚鑰齋 ) 更多 | - | 2022-06-01 | |||
N/A | - | 48 | 獵壓顧鑰構窪願蓋鑰簾(鏇窪製窪衊構選窪廠壓) = 廠繭顧鏇壓襯顧壓遞壓 襯選獵衊壓餘壓繭製選 (襯襯鹽顧窪築構鏇淵壓 ) 更多 | - | 2021-06-01 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用