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Clinical Trials in the UK / NCT07668336
Starting soon 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
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-09
Last updated
2026-08-19

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

OrforglipronDulaglutide

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)

Trial sites (71)

FacilityCityRegionStatus
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology Sacramento California
Rady Children's Hospital San Diego California
Stamford Therapeutics Consortium Stamford Connecticut
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) Atlanta Georgia
CenExel iResearch, LLC Decatur Georgia
Medical Research Partners Ammon Idaho
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas
SUNY Upstate Medical University Syracuse New York
Advantage Clinical Trials The Bronx New York
Central States Research Tulsa Oklahoma
Frontier Clinical Research, LLC Smithfield Pennsylvania
Vanderbilt Health One Hundred Oaks Nashville Tennessee
Gadolin Research Beaumont Texas
Driscoll Children's Hospital Corpus Christi Texas
Proactive Clinical Research LLC Edinburg Texas
Consano Clinical Research, LLC Shavano Park Texas
Victoria Clinical Research Group Victoria Texas
Cliniques universitaires Saint-Luc Brussels Belgium
UZ Gent Ghent Belgium
UZ Leuven Leuven Belgium
Instituto de Pesquisa clinica de Campinas Campinas Brazil
Centro de Pesquisa Sao Lucas Campinas Brazil
Cendi - Endocrinologia e Diabetes Goiânia Brazil
Instituto Méderi de Pesquisa e Saúde Passo Fundo Brazil
Instituto da Crianca com Diabetes Porto Alegre Brazil
Instituto de Pesquisa Clinica São Paulo Brazil
IBTED - Tecnologia e Educação em Diabetes São Paulo Brazil
Avron Hospitals Ahmedabad India
Gujarat Endocrin Pvt Ltd Ahmedabad India
Jawaharlal Nehru Medical College Aligarh India
All India Institute of Medical Sciences Bhubaneswar India
Endolife Speciality Hospitals Guntur India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College Mumbai India
Harmony Health Hub Nashik India
All India Institute of Medical Sciences New Delhi India
Ospedale Pediatrico Salesi Ancona Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
IRCCS Istituto Giannina Gaslini Genova Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino Messina Italy
Ospedale San Raffaele Milan Italy

+ 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