A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Plain-language guide to NCT05803421: phase 3 randomized trial of Insulin Glargine and Orforglipron (Foundayo, non-peptide), 2749 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05803421
Phase: phase 3
Status: completed
Start: 2023-04-03
Completion (planned or actual): 2026-03-16
Participants: 2749 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes; Obesity; Overweight or Obesity; Overweight; Cardiovascular Diseases; Chronic Kidney Disease
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Orforglipron (Foundayo, non-peptide).

The study will last approximately 2 years may include up to 27 visits.

It had two arms (groups): Orforglipron (experimental) and Insulin Glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 2749 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have been diagnosed with type 2 diabetes mellitus (T2DM). Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older. Have HbA1c at screening. Coronary heart disease. Peripheral arterial disease, presumed to be of atherosclerotic origin.

The full record lists 14 inclusion and 10 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to screening; currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-vegf inhibitors.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2023-04-03 with completion listed for 2026-03-16.

It ran at 358 sites in United States (173), Czechia (21), Romania (19), Brazil (18), Argentina (16) and South Korea (13).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Change from Baseline in Hemoglobin A1c (HbA1c), Change from Baseline in Fasting Serum Glucose, Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile, Change from Baseline in Body Weight, Percent Change from Baseline Body Weight and Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Orforglipron (Foundayo, non-peptide) in 2749 people.

With 2749 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Orforglipron (Foundayo, non-peptide): An oral small-molecule GLP-1 receptor agonist (not a peptide); FDA-approved as Foundayo on April 1, 2026 for chronic weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.