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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

Plain-language guide to NCT06972459: phase 3 randomized trial of Orforglipron (Foundayo, non-peptide), 800 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06972459
Phase
phase 3
Status
active, not recruiting
Start
2025-05-15
Completion (planned or actual)
2027-08
Participants
800 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).

Participation in the study will last about 18 months.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (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

The registry lists 800 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 body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:. Obstructive sleep apnea, or. Have a history of at least one unsuccessful dietary effort to lose body weight.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: have type 1 diabetes, type 2 diabetes, or any other types of diabetes; have an unstable body weight within 90 days prior to screening; have new york heart association functional classification iv congestive heart failure or an acute cardiovascular condition within 90 days prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Orforglipron (Foundayo, non-peptide) and who got the comparison, which limits bias.

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 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 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 9 secondary outcomes, for example Change from Baseline in Waist Circumference, Change from Baseline in Body Mass Index (BMI), Change from Baseline in Systolic Blood Pressure (SBP), Percent Change from Baseline in Triglycerides, Change from Baseline in Hemoglobin A1c (HbA1c) and Change from Baseline in Fasting Glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 800 people.

With 800 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.

Our Notes on the Compound

Orforglipron (Foundayo, non-peptide): An oral small-molecule GLP-1 receptor agonist (not a peptide); FDA-approved as Foundayo on April 1, 2026 for chronic weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.