1858-LB：新型 GLP-1 类似物 GZR18 在 Ib/IIa 期试验中使肥胖症受试者的体重降低了 18.6

IF 6.2 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2024-06-21 DOI:10.2337/db24-1858-lb

LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN

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引用次数: 0

摘要

目前尚不清楚多靶点胰岛素类似物与单靶点胰岛素在肥胖症治疗中是否具有更优越的疗效。这项随机、双盲、安慰剂对照、剂量递增的 Ib/IIa 期研究旨在评估 GLP-1 类似物 GZR18 在中国成人肥胖症患者中的疗效和安全性。该研究调查了 GZR18 的减肥潜力，并评估了以不同频率服用 GZR18 的可行性。36名肥胖症患者以3:1的比例被随机分配到接受30毫克的GZR18或安慰剂，为期35周，其中包括31周的剂量递增期。剂量升级到 9 毫克/周后，受试者被分为 QW 或 Q2W 服药亚组。研究终点为体重变化和AEs发生率。经安慰剂调整的GZR18平均体重减轻率在QW组为18.6%，在Q2W组为13.5%，没有出现与IP相关的严重AEs。胃肠道 AEs 报告最多，主要发生在剂量递增初期。GZR18 可显著降低研究参与者的体重，改善代谢状况。在最近涉及类似中国人群的三期试验中，GZR18的减重效果超过了塞马鲁肽（2.4毫克）和替泽帕肽（15毫克）（分别为-9.8%和-17.5%）。与多靶点增量素类似物相比，GZR18具有更优越的体重管理疗效。披露 L. Ji：无。W. Chen: None.R. Dong：无：无。M. Yuan：无。D. Zhao：无。S. Pang：无。L. Zhao：无。J. Zhao：无。Z. Gan：无。

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1858-LB: A Novel GLP-1 Analog, GZR18, Induced an 18.6% Weight Reduction in Subjects with Obesity in a Phase Ib/IIa Trial

It remains unclear whether the superior efficacy of multi-target incretin analogs versus single-target incretins in obesity treatment. This randomized, double-blind, placebo-controlled, dose-escalation phase Ib/IIa study aimed to assess the efficacy and safety of a GLP-1 analog, GZR18, in Chinese adults with obesity. The study investigated the weight loss potential of GZR18 and evaluated the feasibility of administrating GZR18 at different frequencies. Thirty-six participants with obesity were randomized 3:1 to receive 30 mg of GZR18 or a placebo for 35 weeks, including a 31-week dose-escalation period. Upon dose escalation to 9 mg/week, subjects were divided into dosing sub-cohorts of QW or Q2W. Endpoints were body weight change and AEs incidence. The average weight loss of GZR18 adjusted by placebo was 18.6% in QW group and 13.5% in Q2W group, with no IP-related serious AEs. Gastrointestinal AEs were reported most frequently, mainly in early dose-escalation period. GZR18 reduced body weight robustly and improved metabolic profiles in study participants. Its weight-loss effects surpassed those of Semaglutide (2.4 mg) and Tirzepatide (15 mg) in recent phase 3 trials involving similar Chinese populations (-9.8% and -17.5%, respectively). These findings warrant further investigation into GZR18's potential to offer superior weight management efficacy over multi-target incretin analogs. Disclosure L. Ji: None. W. Chen: None. R. Dong: None. M. Yuan: None. D. Zhao: None. S. Pang: None. L. Zhao: None. J. Zhao: None. Z. Gan: None.

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.

1858-LB： 新型 GLP-1 类似物 GZR18 在 Ib/IIa 期试验中使肥胖症受试者的体重降低了 18.6

摘要

1858-LB：新型 GLP-1 类似物 GZR18 在 Ib/IIa 期试验中使肥胖症受试者的体重降低了 18.6