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Recruiting Phase 3

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

NCT07668336 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-07-08
Last updated
2026-10-19

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Orforglipron →Dulaglutide →

Orforglipron: Administered orally

Dulaglutide: Administered SC

Study summary

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. The study will also check how safe these medicines are and how the body processes them.

Participation in the study will last about 61 weeks.

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin * Have HbA1c \> 6.5% to ≤ 11.0% at screening * Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile Exclusion Criteria: * 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 * Have a history of pancreatitis or gallbladder disease * Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening

Primary outcome measure(s)

  • Change from Baseline in Hemoglobin A1c (HbA1c) — Baseline, Week 40

Trial sites (71)

FacilityCityRegionStatus
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology Sacramento California Not Yet Recruiting
Rady Children's Hospital San Diego California Not Yet Recruiting
Stamford Therapeutics Consortium Stamford Connecticut Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) Atlanta Georgia Not Yet Recruiting
CenExel iResearch, LLC Decatur Georgia Recruiting
Medical Research Partners Ammon Idaho Recruiting
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas Recruiting
SUNY Upstate Medical University Syracuse New York Not Yet Recruiting
Advantage Clinical Trials The Bronx New York Recruiting
Central States Research Tulsa Oklahoma Recruiting
Frontier Clinical Research, LLC Smithfield Pennsylvania Recruiting
Vanderbilt Health One Hundred Oaks Nashville Tennessee Not Yet Recruiting
Gadolin Research Beaumont Texas Recruiting
Driscoll Children's Hospital Corpus Christi Texas Recruiting
Proactive Clinical Research LLC Edinburg Texas Recruiting
Consano Clinical Research, LLC Shavano Park Texas Recruiting
Victoria Clinical Research Group Victoria Texas Recruiting
Cliniques universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
Instituto de Pesquisa clinica de Campinas Campinas Brazil Not Yet Recruiting
Centro de Pesquisa Sao Lucas Campinas Brazil Not Yet Recruiting
Cendi - Endocrinologia e Diabetes Goiânia Brazil Not Yet Recruiting
Instituto Méderi de Pesquisa e Saúde Passo Fundo Brazil Not Yet Recruiting
Instituto da Crianca com Diabetes Porto Alegre Brazil Not Yet Recruiting
Instituto de Pesquisa Clinica São Paulo Brazil Not Yet Recruiting
IBTED - Tecnologia e Educação em Diabetes São Paulo Brazil Not Yet Recruiting
Avron Hospitals Ahmedabad India Not Yet Recruiting
Gujarat Endocrin Pvt Ltd Ahmedabad India Not Yet Recruiting
Jawaharlal Nehru Medical College Aligarh India Not Yet Recruiting
All India Institute of Medical Sciences Bhubaneswar India Not Yet Recruiting
Endolife Speciality Hospitals Guntur India Not Yet Recruiting
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College Mumbai India Not Yet Recruiting
Harmony Health Hub Nashik India Not Yet Recruiting
All India Institute of Medical Sciences New Delhi India Not Yet Recruiting
Ospedale Pediatrico Salesi Ancona Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy Not Yet Recruiting
IRCCS Istituto Giannina Gaslini Genova Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Di Messina G. Martino Messina Italy Not Yet Recruiting
Ospedale San Raffaele Milan Italy Not Yet Recruiting

+ 31 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07668336 on ClinicalTrials.gov ↗ ← All trials in the UK