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A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Plain-language guide to NCT07668336: phase 3 randomized trial of Dulaglutide and Orforglipron (Foundayo, non-peptide), 170 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07668336
- Phase
- phase 3
- Status
- recruiting participants
- Start
- 2026-07-08
- Completion (planned or actual)
- 2030-03
- Participants
- 170 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Dulaglutide and Orforglipron (Foundayo, non-peptide).
This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes.
Participation in the study will last about 61 weeks.
It had two arms (groups): Orforglipron (experimental) and Dulaglutide (active comparator).
Participants will receive orforglipron orally.
Participants will receive dulaglutide subcutaneously (SC).
The registry classes the interventions as drug.
Who Took Part
The registry lists 170 planned participants were the target.
It was open to people of any sex aged from 10 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: have type 1 diabetes; after the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome; have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Dulaglutide study did not mask who received what.
It started in 2026-07-08 with completion listed for 2030-03.
It ran at 71 sites in United States (17), Japan (11), India (8), Brazil (7), Italy (7) and Mexico (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change from Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40).
It also tracked 13 secondary outcomes, for example Change from Baseline in HbA1c, Percent Change from Baseline in Body Mass Index (BMI), Percent Change from Baseline in Body Weight, Change from Baseline in Blood Pressure, Percent Change from Baseline in Total Cholesterol and Change from Baseline in Waist Circumference.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Dulaglutide and Orforglipron (Foundayo, non-peptide) in 170 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Dulaglutide compound page and the Orforglipron (Foundayo, non-peptide) compound page, all human trials.
Our Notes on the Compounds
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
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.