Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial

What Was Tested

Researchers studied Tirzepatide in this randomized controlled trial publication.

The aim of this substudy was to characterise the changes in liver fat content (LFC), volume of visceral adipose tissue (VAT), and abdominal subcutaneous adipose tissue (ASAT) in response to tirzepatide or insulin degludec in a subpopulation of the SURPASS-3 study.

Why It Was Studied

Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist under development for the treatment of type 2 diabetes.

Who Took Part

PubMed indexes the participants as adults.

In addition to the main study inclusion criteria, substudy participants had a fatty liver index of at least 60.

Analyses were assessed in the enrolled MRI population, which consisted of participants in the modified intention-to-treat population of the main study who also had a valid MRI at either baseline or after baseline.

How the Study Was Run

The design is described as randomized, open-label and parallel-group.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The Tirzepatide group and the comparison group ran side by side rather than switching.

This substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial was done at 45 medical research centres and hospitals across eight countries (Argentina, Austria, Greece, Hungary, Italy, Romania, Spain, and the USA).

This is a substudy of the trial registered with ClinicalTrials.gov, number NCT03882970, and is complete.

What Was Measured

The subject headings attached to it are Abdominal Fat, Diabetes Mellitus, Type 2, Gastric Inhibitory Polypeptide, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Long-Acting and Liver.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Tirzepatide.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2022 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Tirzepatide compound page, all human trials.