A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

What Was Tested

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

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

401 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). Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes (t1d); have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization; have new york heart association functional classification iv congestive heart failure.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

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

Being open-label, the Orforglipron (Foundayo, non-peptide) study did not mask who received what.

It started in 2023-09-28 with completion listed for 2025-06-05.

It ran at 40 sites in Japan (40).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline to Week 54).

It also tracked 12 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in Fasting Serum Glucose, Change From Baseline in Body Weight, Change From Baseline in Waist Circumference, Change From Baseline in Body Mass Index (BMI) 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 401 people.

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.