A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

What Was Tested

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

Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor.

The study will last about 46 weeks and may include up to 20 visits.

It had four arms (groups): Placebo (placebo comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 546 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 Type 2 Diabetes (T2D). SGLT-2 inhibitor, or. Both metformin and SGLT-2 inhibitor. Have a Body Mass Index (BMI) ≥23.0 kg/m\^2 at baseline.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: have new york heart association functional classification iii-iv congestive heart failure; have had any of the following cardiovascular conditions within 60 days prior to baseline; acute myocardial infarction.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Orforglipron (Foundayo, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-11-10 with completion listed for 2025-09-15.

It ran at 70 sites in United States (25), Japan (14), China (10), Romania (10), Brazil (9) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40).

It also tracked 13 secondary outcomes, for example Change From Baseline in Fasting Serum Glucose (FSG), Percent Change From Baseline in Body Weight, Change From Baseline in Body Weight (kg), Percent Change From Baseline in Non-HDL (Non-high-density Lipoprotein) Cholesterol, Percent Change From Baseline in Triglycerides and Change From Baseline in Systolic Blood Pressure (mmHg).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 546 people.

With 546 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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