An update on tirzepatide for the management of type 2 diabetes: a focus on the phase 3 clinical development program.

IF 2.7 Q3 ENDOCRINOLOGY & METABOLISM

Expert Review of Endocrinology & Metabolism Pub Date : 2023-03-01 DOI:10.1080/17446651.2023.2184796

Juan Pablo Frías

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引用次数: 3

Abstract

Introduction: Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA), received regulatory approval from the U.S. Food and Drug Administration (13 May 2022) and marketing authorization from the European Commission (25 September 2022) for the improvement of glycemic control in adults with type 2 diabetes (T2D). In the phase 3 clinical development program (SURPASS), tirzepatide demonstrated superior glycemic and body weight control compared with placebo and active comparators across a spectrum of patients with T2D.

Areas covered: This review summarizes efficacy and safety results of the tirzepatide T2D phase 3 clinical trials that supported regulatory approvals. Additionally, it discusses a meta-analysis assessing tirzepatide cardiovascular (CV) safety, and provides a brief overview of ongoing late-stage clinical trials in patients with T2D. Information in this review was acquired from peer-reviewed published trials, ClinicalTrials.gov, and the manufacturer's website.

Expert opinion: Based on phase 3 clinical trial data, tirzepatide is the most potent glucose and body weight lowering agent available for the management of T2D. The potential for tirzepatide to improve CV outcomes is currently being assessed in a CV outcomes trial (SURPASS CVOT). Results of this trial are highly anticipated and expected in 2024.

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替西肽治疗2型糖尿病的最新进展:重点是3期临床开发项目

Tirzepatide是一种新型的双糖依赖性胰岛素性多肽(GIP)和胰高血糖素样肽-1 (GLP-1)受体激动剂(RA)，已获得美国食品和药物管理局(2022年5月13日)的监管批准和欧盟委员会(2022年9月25日)的上市许可，用于改善成人2型糖尿病(T2D)的血糖控制。在三期临床开发项目(transcend)中，在一系列T2D患者中，与安慰剂和活性比较物相比，替西帕肽表现出更好的血糖和体重控制。涵盖领域:本综述总结了支持监管部门批准的替泽肽T2D 3期临床试验的有效性和安全性结果。此外，本文还讨论了一项评估替西帕肽心血管(CV)安全性的荟萃分析，并简要概述了正在进行的T2D患者晚期临床试验。本综述中的信息来自同行评议的已发表试验、ClinicalTrials.gov和制造商网站。专家意见:根据3期临床试验数据，替西帕肽是目前治疗T2D最有效的降血糖和降体重药物。目前，一项CV结局试验(transcend CVOT)正在评估替西帕肽改善CV结局的潜力。这项试验的结果备受期待，预计在2024年。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Endocrinology & Metabolism ENDOCRINOLOGY & METABOLISM-

CiteScore

4.80

自引率

0.00%

发文量

期刊介绍： Implicated in a plethora of regulatory dysfunctions involving growth and development, metabolism, electrolyte balances and reproduction, endocrine disruption is one of the highest priority research topics in the world. As a result, we are now in a position to better detect, characterize and overcome the damage mediated by adverse interaction with the endocrine system. Expert Review of Endocrinology and Metabolism (ISSN 1744-6651), provides extensive coverage of state-of-the-art research and clinical advancements in the field of endocrine control and metabolism, with a focus on screening, prevention, diagnostics, existing and novel therapeutics, as well as related molecular genetics, pathophysiology and epidemiology.