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RecruitingPhase 3

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

Eli Lilly and Company · NCT06739122

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
55
US sites recruiting
40
Study start
January 10, 2025
Record last updated
August 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dulaglutide

Conditions: Type 2 Diabetes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Arizona

    Tucson, AZ 85724

    Site contact: 520-626-3197

  • Arkansas Childrens Hospital

    Little Rock, AR 72202-3500

    Site contact: 505-272-5551

  • Division of Endocrinology, Diabetes, and Metabolism

    Los Angeles, CA 90027

    Site contact: Lily Chao

  • UCLA Mattel Children's Hospital

    Los Angeles, CA 90095

    Site contact: 310-203-7631

  • University of California, San Francisco

    San Francisco, CA 94158

    Site contact: 415-514-6234

  • Yale Diabetes Research

    New Haven, CT 06511

    Site contact: 203-737-7177

  • Emerson Clinical Research Institute

    Washington D.C., DC 20009

    Site contact: 202-239-0777

  • Children's National Medical Center

    Washington D.C., DC 20010

    Site contact: 888-884-2327

  • Nemours Children's Health

    Jacksonville, FL 32207

    Site contact: Camila Pereira-Eshraghi

  • D&H National Research Centers, Inc

    Miami, FL 33155

    Site contact: 786-375-6210

  • AdventHealth Orlando

    Orlando, FL 32803

    Site contact: 407-896-2901

  • D&H Tamarac Research Center, LLC

    Tamarac, FL 33321

    Site contact: 786-375-6210

  • University of South Florida

    Tampa, FL 33612

    Site contact: Henry Rodriguez

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, GA 30329

    Site contact: Daniel Hsia

  • Centricity Research Columbus Endocrinology

    Columbus, GA 31904

    Site contact: Steven Leichter

  • St. Luke's Children's Endocrinology and Diabetes

    Boise, ID 83712

    Site contact: 208-381-7340

  • University of Illinois at Chicago

    Chicago, IL 60612

    Site contact: 312-307-9385

  • Center for Diabetes and Metabolic Diseases Indiana University

    Indianapolis, IN 46202

    Site contact: 317-278-9699

  • University of Iowa Stead Family Children's Hospitals

    Iowa City, IA 52242

    Site contact: 319-335-0077

  • Norton Children's Endocrinology

    Louisville, KY 40202

    Site contact: 502-588-3400

  • Johns Hopkins University School of Medicine

    Baltimore, MD 21287

    Site contact: 443-287-9032

  • University of Mississippi Medical Center

    Jackson, MS 39216

    Site contact: 601-815-5000

  • University of New Mexico Hospital

    Albuquerque, NM 87106

    Site contact: 505-272-3073

  • WBMD Pediatrics

    Buffalo, NY 14203

    Site contact: Kathleen Bethin

  • Cohen Children's Medical Center Division of Pediatric Endocrinology

    Hyde Park, NY 11042

    Site contact: 516-472-3750

  • SUNY Upstate Medical University

    Syracuse, NY 13210

    Site contact: 315-464-9006

  • UNC Children's Hospital

    Chapel Hill, NC 27514

    Site contact: 919-966-2333

  • Childrens Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: 513-803-7274

  • Cleveland Clinic Childrens Outpatient Center

    Cleveland, OH 44106

    Site contact: 216-636-2828

  • University of Oklahoma Health Sciences Center

    Oklahoma City, OK 73104

    Site contact: 405-271-6764

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Steven Willi

  • St Christophers Hospital For Children

    Philadelphia, PA 19134

    Site contact: 215-427-7911

  • Prisma Health Pediatric Endocrinology

    Columbia, SC 29203

    Site contact: 803-434-7990

  • Prisma Health Midlands

    Greenville, SC 29615

    Site contact: 864-454-5656

  • Research Institute of Dallas

    Dallas, TX 75231

    Site contact: 248-817-4331

  • Texas Childrens Hospital

    Houston, TX 77030

    Site contact: Siripoom McKay

  • UT Health Houston

    Houston, TX 77030

    Site contact: 713-500-7257

  • University of Utah

    Salt Lake City, UT 84112

    Site contact: Jacqueline Chan

  • Seattle Children's Hospital

    Seattle, WA 98105

    Site contact: 206-987-3897

  • Children's Wisconsin - Milwaukee Campus

    Milwaukee, WI 53226

    Site contact: 414-955-8486

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric… (NCT06739122) | Bored Studies