A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

What Was Tested

In this phase 3 trial, researchers set out to test Orforglipron (Foundayo, non-peptide).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 238 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 a history of at least one self-reported unsuccessful dietary effort to lose body weight. Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. No male contraception is required except in compliance with specific local government study requirements.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: for participants with type 2 diabetes (t2d):; have type 1 diabetes (t1d), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except t2d; have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.

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 2023-07-31 with completion listed for 2025-06-19.

It ran at 16 sites in Japan (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight at Week 72 (time frame: Baseline, Week 72).

It also tracked 20 secondary outcomes, for example Change From Baseline in Body Mass Index (BMI) at Week 72, Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72, Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72, Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72, Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72 and Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 238 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.