A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Orforglipron (Foundayo, non-peptide).

The study will last about 77 weeks and may include up to 22 visits.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1613 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 body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²). Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Either diet/exercise alone or. Up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have type 1 diabetes (t1d), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except t2d; 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 2 (men2) syndrome.

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 2023-06-05 with completion listed for 2025-08-08.

It ran at 136 sites in United States (37), China (18), Germany (15), Czechia (12), Argentina (11) and Australia (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Body Weight (time frame: Baseline, Week 72).

It also tracked 14 secondary outcomes, for example Change From Baseline in Waist Circumference, Change From Baseline in Hemoglobin A1c (HbA1c) %, Change From Baseline in Fasting Serum Glucose (FSG) and Percent Change From Baseline in Fasting Insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 1613 people.

With 1613 participants it is a large trial for this field.

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.