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HomeTrials › NCT06739122

Type 2 diabetes · Phase 3 · Recruiting now

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

NCT06739122 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 41 US sites. It's studying Dulaglutide for type 2 diabetes.

Who can joinAll sexes, 10 Years – 17 Years
Healthy volunteersNo — diagnosis required
What you'd takeDulaglutide
Study length~2.9 years overall
Planned participants55
TypeInterventional (you receive treatment)

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

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

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. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion Criteria: * Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes 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) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Study sites by state

Arizona

  • University of Arizona — Tucson · Recruiting now

Arkansas

  • Arkansas Childrens Hospital — Little Rock · Recruiting now

California

  • Division of Endocrinology, Diabetes, and Metabolism — Los Angeles · Recruiting now
  • UCLA Mattel Children's Hospital — Los Angeles · Recruiting now
  • University of California, San Francisco — San Francisco · Recruiting now

Colorado

  • Children's Hospital of Colorado — Denver · Opening soon

Connecticut

  • Yale Diabetes Research — New Haven · Recruiting now

District of Columbia

  • Emerson Clinical Research Institute — Washington D.C. · Recruiting now
  • Children's National Medical Center — Washington D.C. · Opening soon

Florida

  • Nemours Children's Health — Jacksonville · Recruiting now
  • D&H National Research Centers, Inc — Miami · Recruiting now
  • AdventHealth Orlando — Orlando · Recruiting now
  • D&H Tamarac Research Center, LLC — Tamarac · Recruiting now
  • University of South Florida — Tampa · Recruiting now

Georgia

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta · Recruiting now
  • Centricity Research Columbus Endocrinology — Columbus · Recruiting now

Idaho

  • St. Luke's Children's Endocrinology and Diabetes — Boise · Recruiting now

Illinois

  • University of Illinois at Chicago — Chicago · Recruiting now

Indiana

  • Center for Diabetes and Metabolic Diseases Indiana University — Indianapolis · Opening soon

Iowa

  • University of Iowa Stead Family Children's Hospitals — Iowa City · Recruiting now

Kentucky

  • Norton Children's Endocrinology — Louisville · Recruiting now

Maryland

  • Johns Hopkins University School of Medicine — Baltimore · Recruiting now

Mississippi

  • University of Mississippi Medical Center — Jackson · Recruiting now

New Mexico

  • University of New Mexico Hospital — Albuquerque · Recruiting now

New York

  • WBMD Pediatrics — Buffalo · Recruiting now
  • Cohen Children's Medical Center Division of Pediatric Endocrinology — Hyde Park · Recruiting now
  • SUNY Upstate Medical University — Syracuse · Recruiting now

North Carolina

  • UNC Children's Hospital — Chapel Hill · Recruiting now

Ohio

  • Childrens Hospital Medical Center — Cincinnati · Recruiting now
  • Cleveland Clinic Childrens Outpatient Center — Cleveland · Recruiting now

Oklahoma

  • University of Oklahoma Health Sciences Center — Oklahoma City · Recruiting now

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia · Recruiting now
  • St Christophers Hospital For Children — Philadelphia · Opening soon

South Carolina

  • Prisma Health Pediatric Endocrinology — Columbia · Recruiting now
  • Prisma Health Midlands — Greenville · Recruiting now

Texas

  • Research Institute of Dallas — Dallas · Recruiting now
  • Texas Childrens Hospital — Houston · Recruiting now
  • UT Health Houston — Houston · Recruiting now

Utah

  • University of Utah — Salt Lake City · Recruiting now

Washington

  • Seattle Children's Hospital — Seattle · Recruiting now

Wisconsin

  • Children's Wisconsin - Milwaukee Campus — Milwaukee · Opening soon

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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