Clinical trial
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Opening soon · Phase 3 · 6 countries · Registry ID NCT07668336
Opening soonPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age10 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2
Full registry 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
Treatments and study arms
Orforglipron
Drug
Administered orally
Dulaglutide
Drug
Administered SC
Primary outcomes
Change from Baseline in Hemoglobin A1c (HbA1c)Baseline, Week 40
Study locations
71 locations were listed when this page was built. The first 40 are shown.
Cliniques universitaires Saint-Luc🇧🇪 Brussels, Belgium
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Philippe LysyPrincipal Investigator
UZ Gent🇧🇪 Ghent, Belgium
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Saskia van der StraatenPrincipal Investigator
UZ Leuven🇧🇪 Leuven, Belgium
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Kristina CasteelsPrincipal Investigator
Centro de Pesquisa Sao Lucas🇧🇷 Campinas, Brazil
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Mila CunhaPrincipal Investigator
Instituto de Pesquisa clinica de Campinas🇧🇷 Campinas, Brazil
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Sylka RodovalhoPrincipal Investigator
Cendi - Endocrinologia e Diabetes🇧🇷 Goiânia, Brazil
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Nelson RassiPrincipal Investigator
Instituto Méderi de Pesquisa e Saúde🇧🇷 Passo Fundo, Brazil
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Hugo Kurtz LisboaPrincipal Investigator
Instituto da Crianca com Diabetes🇧🇷 Porto Alegre, Brazil
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Balduino TschiedelPrincipal Investigator
IBTED - Tecnologia e Educação em Diabetes🇧🇷 São Paulo, Brazil
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Monica GabbayPrincipal Investigator
Avron Hospitals🇮🇳 Ahmedabad, India
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Tiven MarwahPrincipal Investigator
Gujarat Endocrin Pvt Ltd🇮🇳 Ahmedabad, India
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parag ShahPrincipal Investigator
All India Institute of Medical Sciences🇮🇳 Bhubaneswar, India
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Kishore BeheraPrincipal Investigator
Endolife Speciality Hospitals🇮🇳 Guntur, India
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Kongara SrikanthPrincipal Investigator
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College🇮🇳 Mumbai, India
Manjiri KarlekarPrincipal Investigator
All India Institute of Medical Sciences🇮🇳 New Delhi, India
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Rajesh KhadgawatPrincipal Investigator
Ospedale Pediatrico Salesi🇮🇹 Ancona, Italy
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Valentino CherubiniPrincipal Investigator
Azienda Ospedaliera Universitaria Meyer IRCCS🇮🇹 Florence, Italy
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Lorenzo LenziPrincipal Investigator
IRCCS Istituto Giannina Gaslini🇮🇹 Genova, Italy
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Mohamad MaghniePrincipal Investigator
Azienda Ospedaliera Universitaria Di Messina G. Martino🇮🇹 Messina, Italy
Giuseppina SalzanoPrincipal Investigator
Ospedale San Raffaele🇮🇹 Milan, Italy
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riccardo bonfantiPrincipal Investigator
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento🇮🇹 Verona, Italy
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Claudio MaffeisPrincipal Investigator
Nihon University Hospital🇯🇵 Chiyoda-ku, Japan
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Junichi SuzukiPrincipal Investigator
Fukuoka Children's Hospital🇯🇵 Fukuoka, Japan
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Kenichi MiyakoPrincipal Investigator
Saitama Medical University Hospital🇯🇵 Iruma, Japan
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Toru KikuchiPrincipal Investigator
Shiga General Hospital🇯🇵 Moriyama, Japan
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Katsuyuki MatsuiPrincipal Investigator
Niigata University Medical & Dental Hospital🇯🇵 Niigata, Japan
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Yohei OgawaPrincipal Investigator
Osaka City General Hospital🇯🇵 Osaka, Japan
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Jun MoriPrincipal Investigator
Saitama City Hospital🇯🇵 Saitama, Japan
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Masayuki AkashiPrincipal Investigator
Sendai City Hospital - Asutonagamachi🇯🇵 Sendai, Japan
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Ikuma FujiwaraPrincipal Investigator
Shizuoka Children's Hospital🇯🇵 Shizuoka, Japan
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Shinichiro SanoPrincipal Investigator
Urakami Pediatric Endocrinology and Diabetes Clinic🇯🇵 Tokyo, Japan
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Tatsuhiko UrakamiPrincipal Investigator
Juntendo University Urayasu Hospital🇯🇵 Urayasu, Japan
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Hiroaki SatohPrincipal Investigator
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.🇲🇽 Ciudad Madero, Mexico
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Rafael Violante OrtizPrincipal Investigator
Centro de Investigacion Medica de Occidente, S.C.🇲🇽 Guadalajara, Mexico
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Emilia Pelayo OrozcoPrincipal Investigator
Centro de investigación y control metabólico🇲🇽 Monterrey, Mexico
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Samantha Garza FuentesPrincipal Investigator
Clínica García Flores SC🇲🇽 Monterrey, Mexico
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Pedro García HernándezPrincipal Investigator