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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07668336

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Orforglipron (Drug)
    Administered orally
  • Dulaglutide (Drug)
    Administered SC

Eligibility criteria

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

Conditions

Diabetes Mellitus, Type 2

Locations

  • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology — Sacramento, California, United States
  • Rady Children's Hospital — San Diego, California, United States
  • Stamford Therapeutics Consortium — Stamford, Connecticut, United States
  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) — Atlanta, Georgia, United States
  • CenExel iResearch, LLC — Decatur, Georgia, United States
  • Medical Research Partners — Ammon, Idaho, United States
  • Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
  • SUNY Upstate Medical University — Syracuse, New York, United States
  • Advantage Clinical Trials — The Bronx, New York, United States
  • Central States Research — Tulsa, Oklahoma, United States
  • Frontier Clinical Research, LLC — Smithfield, Pennsylvania, United States
  • Vanderbilt Health One Hundred Oaks — Nashville, Tennessee, United States
  • Gadolin Research — Beaumont, Texas, United States
  • Driscoll Children's Hospital — Corpus Christi, Texas, United States
  • Proactive Clinical Research LLC — Edinburg, Texas, United States
  • Consano Clinical Research, LLC — Shavano Park, Texas, United States
  • Victoria Clinical Research Group — Victoria, Texas, United States
  • 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
  • University of Naples Federico II — Naples, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento — Verona, Italy
  • Nihon University Hospital — Chiyoda-ku, Japan
  • Fukuoka Children's Hospital — Fukuoka, Japan
  • Saitama Medical University Hospital — Iruma, Japan
  • Shiga General Hospital — Moriyama, Japan
  • Niigata University Medical & Dental Hospital — Niigata, Japan
  • Osaka City General Hospital — Osaka, Japan
  • Saitama City Hospital — Saitama, Japan
  • Sendai City Hospital - Asutonagamachi — Sendai, Japan
  • Shizuoka Children's Hospital — Shizuoka, Japan
  • Urakami Pediatric Endocrinology and Diabetes Clinic — Tokyo, Japan
  • Juntendo University Urayasu Hospital — Urayasu, Japan
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. — Ciudad Madero, Mexico
  • Centro de Investigacion Medica de Occidente, S.C. — Guadalajara, Mexico
  • UBAM Unidad Biomedica Avanzada Monterrey — Monterrey, Mexico
  • Clínica García Flores SC — Monterrey, Mexico
  • Centro de investigación y control metabólico — Monterrey, Mexico
  • Soon Chun Hyang University Bucheon Hospital — Bucheon-si, South Korea
  • Kyungpook National University Chilgok Hospital — Deagu, South Korea
  • Chungnam national university hospital — Junggu, South Korea
  • Seoul National University Bundang Hospital — Seongnam, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • H.R.U Málaga - Hospital General — Málaga, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
  • China Medical University Hospital — Taichung, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
  • Hull Royal Infirmary — Hull, United Kingdom
  • Alder Hey Children's Hospital — Liverpool, United Kingdom
  • Royal London Hospital — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record