Menu
Not yet recruiting NCT07668336

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

Phase III Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orforglipron, Dulaglutide.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Brazil, India, Italy +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Orforglipron
    Administered orally
  • Drug Dulaglutide
    Administered SC

Primary outcome measures

  • Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 40]
Secondary outcome measures (12)
  • Change from Baseline in HbA1c [Time frame: Baseline, Week 52]
  • Percentage of Participants with HbA1c ≤6.5% [Time frame: Week 40]
  • Percent Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 40]
  • Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL [Time frame: Baseline, during 2 weeks prior to Week 40]
  • Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 40]
  • Change from Baseline in Blood Pressure [Time frame: Baseline, Week 40]
  • Percent Change from Baseline in Total Cholesterol [Time frame: Baseline, Week 40]
  • Change from Baseline in Waist Circumference [Time frame: Baseline, Week 40]
  • Change from Baseline in Tanner Staging [Time frame: Baseline, Week 52]
  • Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B) [Time frame: Baseline, Week 40]
  • Change from Baseline in the EQ-5D-Y-5L [Time frame: Baseline, Week 40]
  • Number of Participants by Acceptability Response Category [Time frame: Baseline, Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • 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
  • … and 9 more centers
Japan · 11 centers
  • 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
  • … and 3 more centers
India · 8 centers
  • 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
Brazil · 7 centers
  • 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
Italy · 7 centers
  • 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
Mexico · 5 centers
  • 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 centers
  • 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
Belgium · 3 centers
  • Cliniques universitaires Saint-Luc — Brussels
  • UZ Gent — Ghent
  • UZ Leuven — Leuven
Spain · 3 centers
  • Hospital Universitari Vall d'Hebron — Barcelona
  • H.R.U Málaga - Hospital General — Málaga
  • Hospital Universitario Virgen Del Rocio — Seville
United Kingdom · 3 centers
  • Hull Royal Infirmary — Hull
  • Alder Hey Children's Hospital — Liverpool
  • Royal London Hospital — London
Taiwan · 2 centers
  • China Medical University Hospital — Taichung
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗