Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial

What Was Tested

The paper reports a study of Tirzepatide and GIP (Gastric Inhibitory Polypeptide), published as a randomized controlled trial.

Who Took Part

The age groups tagged for this paper are children and teenagers, both men and women.

The researchers conducted a phase 3, double-blind, placebo-controlled, multicentre (39 sites), multinational (eight countries) trial over 30 weeks, followed by an open-label extension for 22 weeks in which all participants received tirzepatide.

How the Study Was Run

The design is described as randomized, double-blind, open-label, placebo-controlled and multicenter.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

A placebo (an inactive look-alike) gave the Tirzepatide group a baseline to be compared against.

A time span of 30 weeks appears in the methods.

Randomisation was stratified by age group (≤14 years or >14 years) and antihyperglycaemic medication use (metformin, basal insulin, or both).

The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 30.

This completed trial is registered with ClinicalTrials.gov (NCT05260021).

What Was Measured

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Hypoglycemic Agents, Tirzepatide, Glycated Hemoglobin, Blood Glucose, Gastric Inhibitory Polypeptide and Metformin.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Tirzepatide and GIP (Gastric Inhibitory Polypeptide) over 30 weeks.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2025 (Lancet (London, England)), a journal based in England.

More context: the Tirzepatide compound page and the GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.