A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

What Was Tested

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

The study has two phases: a main phase and an extension phase.

The main phase of the study lasted 72 weeks.

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

Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 3127 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 BMI. ≥30.0 kilogram/square meter (kg/m²),. ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:. Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma; have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening; have family (first-degree relative) or personal history of medullary thyroid cancer (mtc) or multiple endocrine neoplasia (men)2 syndrome.

How the Study Was Run

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

The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.

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 2023-06-05 with completion listed for 2025-07-25.

It ran at 138 sites in United States (43), China (20), Japan (18), Brazil (14), Spain (13) and India (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Body Weight (Primary Treatment Period) (time frame: Baseline, Week 72).

It also tracked 11 secondary outcomes, for example Change From Baseline in Waist Circumference (Primary Treatment Period), Change From Baseline in HbA1c (Primary Treatment Period), Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period), Percent Change From Baseline in Fasting Insulin (Primary Treatment Period), Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization) and Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 3127 people.

With 3127 participants it is a large trial for this field.

Its status is active not recruiting; 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.