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

Официальное название

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes

Обзор

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.

Вмешательства

• Препарат Orforglipron
  Administered orally
• Препарат Dulaglutide
  Administered SC

Первичные конечные точки

• Change from Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, Week 40]

Вторичные конечные точки (12)

• Change from Baseline in HbA1c [Срок оценки: Baseline, Week 52]
• Percentage of Participants with HbA1c ≤6.5% [Срок оценки: Week 40]
• Percent Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 40]
• Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL [Срок оценки: Baseline, during 2 weeks prior to Week 40]
• Percent Change from Baseline in Body Weight [Срок оценки: Baseline, Week 40]
• Change from Baseline in Blood Pressure [Срок оценки: Baseline, Week 40]
• Percent Change from Baseline in Total Cholesterol [Срок оценки: Baseline, Week 40]
• Change from Baseline in Waist Circumference [Срок оценки: Baseline, Week 40]
• Change from Baseline in Tanner Staging [Срок оценки: Baseline, Week 52]
• Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B) [Срок оценки: Baseline, Week 40]
• Change from Baseline in the EQ-5D-Y-5L [Срок оценки: Baseline, Week 40]
• Number of Participants by Acceptability Response Category [Срок оценки: Baseline, Week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 17 центров

• Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology — Sacramento
• Rady Children's Hospital — San Diego
• Stamford Therapeutics Consortium — Stamford
• Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) — Atlanta
• CenExel iResearch, LLC — Decatur
• Medical Research Partners — Ammon
• Cotton O'Neil Diabetes & Endocrinology — Topeka
• SUNY Upstate Medical University — Syracuse
• … и ещё 9 центров

Япония · 11 центров

• Nihon University Hospital — Chiyoda-ku
• Fukuoka Children's Hospital — Fukuoka
• Saitama Medical University Hospital — Iruma
• Shiga General Hospital — Moriyama
• Niigata University Medical & Dental Hospital — Niigata
• Osaka City General Hospital — Osaka
• Saitama City Hospital — Saitama
• Sendai City Hospital - Asutonagamachi — Sendai
• … и ещё 3 центра

Индия · 8 центров

• Avron Hospitals — Ahmedabad
• Gujarat Endocrin Pvt Ltd — Ahmedabad
• Jawaharlal Nehru Medical College — Aligarh
• All India Institute of Medical Sciences — Bhubaneswar
• Endolife Speciality Hospitals — Guntur
• King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College — Mumbai
• Harmony Health Hub — Nashik
• All India Institute of Medical Sciences — New Delhi

Бразилия · 7 центров

• Instituto de Pesquisa clinica de Campinas — Campinas
• Centro de Pesquisa Sao Lucas — Campinas
• Cendi - Endocrinologia e Diabetes — Goiânia
• Instituto Méderi de Pesquisa e Saúde — Passo Fundo
• Instituto da Crianca com Diabetes — Porto Alegre
• Instituto de Pesquisa Clinica — São Paulo
• IBTED - Tecnologia e Educação em Diabetes — São Paulo

Италия · 7 центров

• Ospedale Pediatrico Salesi — Ancona
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
• IRCCS Istituto Giannina Gaslini — Genova
• Azienda Ospedaliera Universitaria Di Messina G. Martino — Messina
• Ospedale San Raffaele — Milan
• University of Naples Federico II — Naples
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento — Verona

Мексика · 5 центров

• Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. — Ciudad Madero
• Centro de Investigacion Medica de Occidente, S.C. — Guadalajara
• UBAM Unidad Biomedica Avanzada Monterrey — Monterrey
• Clínica García Flores SC — Monterrey
• Centro de investigación y control metabólico — Monterrey

South Korea · 5 центров

• Soon Chun Hyang University Bucheon Hospital — Bucheon-si
• Kyungpook National University Chilgok Hospital — Deagu
• Chungnam national university hospital — Junggu
• Seoul National University Bundang Hospital — Seongnam
• Seoul National University Hospital — Seoul

Бельгия · 3 центра

• Cliniques universitaires Saint-Luc — Brussels
• UZ Gent — Ghent
• UZ Leuven — Leuven

Испания · 3 центра

• Hospital Universitari Vall d'Hebron — Barcelona
• H.R.U Málaga - Hospital General — Málaga
• Hospital Universitario Virgen Del Rocio — Seville

Великобритания · 3 центра

• Hull Royal Infirmary — Hull
• Alder Hey Children's Hospital — Liverpool
• Royal London Hospital — London

Тайвань · 2 центра

• China Medical University Hospital — Taichung
• Chang Gung Medical Foundation-Linkou Branch — Taoyuan

Идентификаторы

NCT: NCT07668336 · 18654 · J2A-MC-GZGY · 2025-524811-35-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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