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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Administered orally
Administered SC
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
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
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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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
...and 61 more locations
Time frame: Baseline, Week 40
Number of Participants by Acceptability Response Category
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
Time frame: Predose through Week 30