A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

What Was Tested

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

It had three arms (groups): Orforglipron (experimental), Orforglipron to Placebo (experimental) and Placebo to Orforglipron (experimental).

Participants will receive orforglipron orally.

Participants will receive orforglipron orally followed by placebo orally.

Participants will receive placebo orally followed by orforglipron orally.

The registry classes the interventions as drug.

Who Took Part

2001 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: Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia). Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: have type 1 diabetes, type 2 diabetes, or any other type of diabetes; do not have a stable body weight within 90 days before screening; have a documented obesity diagnosis or self-reported history of bmi ≥30 kg/m² (or an equivalent region-specific threshold).

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.

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

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 2026-08-26 with completion listed for 2029-08.

It ran at 180 sites in United States (80), Argentina (20), South Korea (12), China (11), Germany (10) and Spain (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Onset of Obesity Related Complications or Class 1 Obesity (time frame: Baseline to Week 104).

It also tracked 12 secondary outcomes, for example Percent Change from Baseline in Body Weight, Time to Onset of Waist-to-Height Ratio ≥0.6, Change from Baseline in Waist Circumference, Time to Onset of Class 1 Obesity, Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia and Time to Onset of Type 2 Diabetes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 2001 people.

With 2001 participants it is a large trial for this field.

It is still 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.