A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Plain-language guide to NCT06672549: phase 3 interventional trial of Orforglipron (Foundayo, non-peptide), 125 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06672549
Phase: phase 3
Status: recruiting participants
Start: 2024-11-18
Completion (planned or actual): 2027-02
Participants: 125 (estimated)
Design: na, open label (everyone knows who gets what), screening
Conditions studied: Obesity; Overweight
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

It had 1 arm (groups): Orforglipron (ISA PW01) (experimental).

Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.

The registry classes the interventions as drug.

More on the Plan

The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs.

The ISAs may start independently of other ISAs as interventions become available for clinical testing.

PWMP results will be reported when all the ISA's complete.

Who Took Part

125 planned participants were the target.

It was open to people of any sex aged from 6 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR. Type 2 diabetes (T2D). Obstructive sleep apnea. Metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD).

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: gastric bypass; sleeve gastrectomy; restrictive bariatric surgery, such as lap-band® gastric banding, or.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Orforglipron (Foundayo, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-11-18 with completion listed for 2027-02.

It ran at 116 sites in United States (50), Japan (9), Poland (9), Italy (7), United Kingdom (7) and Israel (6).

Its stated primary purpose is screening.

What Was Measured

Primary outcome: Number of Participants Allocated to Each ISA (time frame: Baseline to Week 72).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Orforglipron (Foundayo, non-peptide) in 125 people.

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.

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.

Orforglipron (Foundayo, non-peptide) in the library

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.