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

Mar 13, 2023Expert review of endocrinology & metabolism

Tirzepatide for managing type 2 diabetes: latest results from phase 3 trials

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Abstract

Tirzepatide received regulatory approval on 13 May 2022 for improving glycemic control in adults with type 2 diabetes.

In phase 3 clinical trials, tirzepatide showed superior control of blood sugar and body weight compared to placebo and other treatments.
Efficacy and safety results from these trials supported its regulatory approvals.
A meta-analysis evaluating tirzepatide's cardiovascular safety is also discussed.
Ongoing late-stage trials are assessing its potential to improve cardiovascular outcomes.

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

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