Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial

What Was Tested

This randomized controlled trial paper looks at Orforglipron (Foundayo, non-peptide).

Orforglipron is an oral, non-peptide GLP-1 receptor agonist.

Who Took Part

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

All participants had established cardiovascular or chronic kidney disease.

How the Study Was Run

The researchers set it up as a randomized, open-label, multicenter and parallel-group study.

Because people in this Orforglipron (Foundayo, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Orforglipron (Foundayo, non-peptide) study: the participants and staff both knew the treatment.

More than one site took part, so the participants came from several places.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

This event-driven, phase 3, multicentre, randomised, open-label, active comparator, parallel-group study was conducted in 317 sites across 16 countries and territories.

This trial was registered on ClinicalTrials.gov (NCT05803421) and is completed.

What Was Measured

Topics PubMed links to this paper include Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Heart Disease Risk Factors, Hypoglycemic Agents, Insulin Glargine and Fluorine Compounds.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Orforglipron (Foundayo, non-peptide).

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2026 (Lancet (London, England)), a journal based in England.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.