A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

What Was Tested

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

The study will last approximately 54 weeks.

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: 559 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. Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have type 1 diabetes; have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization; currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Orforglipron (Foundayo, non-peptide) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Orforglipron (Foundayo, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-08-09 with completion listed for 2025-04-03.

It ran at 89 sites in United States (41), China (15), Japan (14), India (9), Mexico (8) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (time frame: Baseline, Week 40).

It also tracked 11 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, Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol, Percent Change From Baseline in Triglycerides and Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 559 people.

With 559 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.