A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Plain-language guide to NCT06045221: phase 3 randomized trial of Semaglutide and Orforglipron (Foundayo, non-peptide), 1698 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06045221
Phase: phase 3
Status: completed
Start: 2023-09-22
Completion (planned or actual): 2025-08-22
Participants: 1698 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1698 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.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: have type 1 diabetes; have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization; have a new york heart association functional classification iv congestive heart failure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2023-09-22 with completion listed for 2025-08-22.

It ran at 131 sites in United States (64), China (21), Argentina (17), Mexico (16), Japan (9) and Puerto Rico (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 20 secondary outcomes, for example Percent Change From Baseline in Body Weight, Change From Baseline in Body Weight, Change From Baseline in Fasting Serum Glucose, Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG), Change From Baseline in Systolic Blood Pressure (SBP) and Change From Baseline in Diastolic Blood Pressure (DBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Orforglipron (Foundayo, non-peptide) in 1698 people.

With 1698 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 Semaglutide compound page and the Orforglipron (Foundayo, non-peptide) compound page, all human trials.

Our Notes on the Compounds

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

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.

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.