A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

What Was Tested

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

Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

It had ten arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (Study GZP1) (placebo comparator).

Participants will receive orforglipron orally.

Participants will receive orforglipron orally.

Participants will receive orforglipron orally.

The registry classes the interventions as drug.

Who Took Part

1400 planned participants were the target.

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: See study GZP1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes. See study GZP2 for eligibility criteria relevant to participants with type 2 diabetes.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2025-05-15 with completion listed for 2027-08.

It ran at 80 sites in United States (35), Japan (13), China (12), Germany (7), Argentina (6) and Czechia (5).

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): Number of Participants Allocated to Each Study (time frame: Baseline to Week 4).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 1400 people.

With 1400 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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