A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
10–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, aged 10 to below 18 years at screening visit
Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
Have HbA1c \>6.5% to ≤11% at screening
Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region.
You may not be if
Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
Had chronic or acute pancreatitis any time prior to study entry
Female participants who are pregnant or breast feeding or intending to become pregnant.
Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Clareo Health | A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
