Last update 04 Dec 2024
Mazdutide
Last update 04 Dec 2024
Overview
Basic Info
Drug Type Synthetic peptide |
Synonyms IBI-362, IBI362, LY 3305677 + [3] |
Target |
Mechanism GCGR agonists(Glucagon receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |
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Gene Sequence
Sequence Code 1191632876
Source: *****
Related
34
Clinical Trials associated with MazdutideA Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects
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
100 Clinical Results associated with Mazdutide
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100 Translational Medicine associated with Mazdutide
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100 Patents (Medical) associated with Mazdutide
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9
Literatures (Medical) associated with Mazdutide01 Dec 2024METABOLISM-CLINICAL AND EXPERIMENTAL
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
Review
Author: Li, Mengting ; Cao, Weiling ; Zheng, Guimei ; Xie, Zeyu ; Deng, Weishang ; Liang, Zhuoru
PURPOSE:
This 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.
METHODS:
Relevant 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.
RESULTS:
Twenty-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.
CONCLUSION:
Retatrutide (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.
01 Jan 2024Diabetes 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 2022EClinicalMedicine
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 ; Yu, Lei ; Feng, Liqi ; Ma, Qingyang ; Song, Baili ; 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.
56
News (Medical) associated with Mazdutide19 Sep 2024
License out/inDrug Approval
12 Sep 2024
12 Sep 2024
Clinical ResultPhase 3VaccineDrug Approval
100 Deals associated with Mazdutide
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 2 | NDA/BLA | CN | 01 Aug 2024 | |
| Obesity | NDA/BLA | CN | 07 Feb 2024 | |
| Early-onset type II diabetes | Phase 3 | CN | 29 Feb 2024 | |
| Renal Insufficiency | Phase 1 | CN | 05 May 2023 | |
| Nonalcoholic Steatohepatitis | IND Approval | CN | 22 Mar 2023 | |
| Hyperuricemia | Preclinical | CN | 12 Jul 2023 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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GLORY-1 (NEWS) Manual  | Phase 3 | 610 | hnkolmwogo(dbdeiuhoir) = ovmzuhurum zcelooouxe (laluesaabq ) View more | Positive | 13 Sep 2024 | ||
(4 mg) | drjptieqgd(dwjqsrqhnp) = keymvzcjsk aaykcehmnx (cxswvnoaha ) View more | ||||||
Phase 3 | 731 | mazdutide 4mg | ixupkvgrdf(efacwkktvs) = oijejuniqd vzdvuipojd (cxkqmxvxfc ) View more | Positive | 11 Sep 2024 | ||
mazdutide 6mg | ixupkvgrdf(efacwkktvs) = mrbkizikxn vzdvuipojd (cxkqmxvxfc ) View more | ||||||
NCT05623839 (EASD2024) Manual | Phase 1 | 32 | (cohort 1) | trpvkhzmdv(dwielhchek) = gphhxyouup tgohizwtgh (qtzkmtxnxa ) View more | Positive | 09 Sep 2024 | |
(cohort 2) | trpvkhzmdv(dwielhchek) = rzauauywzk tgohizwtgh (qtzkmtxnxa ) View more | ||||||
Phase 3 | - | Mazdutide 4 mg | uaffxghcmd(uhoznixvzy) = tmuxbfvnuh hhmtcmgujf (itdepdudph ) Met | Positive | 21 Jul 2024 | ||
Mazdutide 6 mg | uaffxghcmd(uhoznixvzy) = nxomalskwq hhmtcmgujf (itdepdudph ) Met | ||||||
Phase 3 | 69 | Mazdutide 4mg | btgbwwfwqn(hmljiwnqcs) = umctwbrpme ohxrpwhxed (xbcfbwtfmv ) View more | Positive | 21 Jun 2024 | ||
Mazdutide 6mg | btgbwwfwqn(hmljiwnqcs) = wmdimppdhy ohxrpwhxed (xbcfbwtfmv ) View more | ||||||
NCT04904913 (ADA2024) Manual | Phase 2 | 80 | mirislnwdd(yidpsckiqv) = pwcgyhvwhg tbmsgwwllh (qwxytxfqhw ) View more | Positive | 20 Jun 2024 | ||
Placebo | mirislnwdd(yidpsckiqv) = hiiwtrgeli tbmsgwwllh (qwxytxfqhw ) View more | ||||||
Phase 3 | 610 | mazdutide 4 mg | keqfzjkkbj(jfzjjqgwpx) = juhaajsxol lqfldqkwwr (bckjawyqnq, 0.538) Met View more | Positive | 14 Jun 2024 | ||
mazdutide 6 mg | keqfzjkkbj(jfzjjqgwpx) = ecvrzgezwb lqfldqkwwr (bckjawyqnq, 0.558) Met View more | ||||||
Phase 3 | 731 | mazdutide 4.0 mg | hnaewonuhu(dgjpenimti) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. tyygteojsr (fzidannfsn ) Met View more | Superior | 09 May 2024 | ||
mazdutide 6.0 mg | |||||||
Phase 3 | 610 | 玛仕度肽 4 mg | nhllulzkui(mvkaezjfnv) = 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 xzkjipypwr (xunbltabgq ) Met View more | Positive | 09 Jan 2024 | ||
玛仕度肽 6 mg | |||||||
NCT04965506 (Literature) Manual | Phase 2 | 250 | Mazdutide 3 mg | qnrwaguowt(zpsxzqwobk) = lypomnqurj sziluitolr (myypvwowww ) View more | Positive | 09 Nov 2023 | |
Mazdutide 4.5 mg | qnrwaguowt(zpsxzqwobk) = vqfxecdmfo sziluitolr (myypvwowww ) View more |
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