What this trial means for you
This study is opening soon at 17 US sites. It's studying Orforglipron, Dulaglutide for diabetes mellitus, type 2.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
California
- Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology, Sacramento
- Rady Children's Hospital, San Diego
Connecticut
- Stamford Therapeutics Consortium, Stamford
Georgia
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP), Atlanta
- CenExel iResearch, LLC, Decatur
Idaho
- Medical Research Partners, Ammon
Kansas
- Cotton O'Neil Diabetes & Endocrinology, Topeka
New York
- SUNY Upstate Medical University, Syracuse
- Advantage Clinical Trials, The Bronx
Oklahoma
- Central States Research, Tulsa
Pennsylvania
- Frontier Clinical Research, LLC, Smithfield
Tennessee
- Vanderbilt Health One Hundred Oaks, Nashville
Texas
- Gadolin Research, Beaumont
- Driscoll Children's Hospital, Corpus Christi
- Proactive Clinical Research LLC, Edinburg
- Consano Clinical Research, LLC, Shavano Park
- Victoria Clinical Research Group, Victoria
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.