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NCT06739122RecruitingPhase 3

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

A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
55 (estimated)
First submitted
13 Dec 2024
Start date
10 Jan 2025
Primary completion date
Dec 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT06739122

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 55
  • From 10 Jan 2025 to the primary completion date, Dec 2027
  • 51 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Have Type 1 diabetes
  • After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

Lab values

  • Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening

Other

  • Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months

Who the study is looking for

  • 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

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro de Investigaciones Medicas Mar Del Plata
Coordinator of this site? Confirm its status
Mar del PlataArgentinaNot yet recruiting
INECO Neurociencias Oroño
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaRecruiting
Go Centro Medico San Nicolás
Coordinator of this site? Confirm its status
San NicolásArgentinaRecruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Coordinator of this site? Confirm its status
Ciudad MaderoMexicoNot yet recruiting
Hospital Angeles (HA) - Puebla
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Puebla CityMexicoNot yet recruiting
Clínica Cemain
Coordinator of this site? Confirm its status
TampicoMexicoNot yet recruiting
Innovacion y Desarrollo de Estrategias en Salud SA de CV
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TlalpanMexicoNot yet recruiting
Arké SMO S.A de C.V
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VeracruzMexicoNot yet recruiting
University of New Mexico Hospital
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Johns Hopkins University School Of Medicine
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
St. Luke's Children's Endocrinology and Diabetes
Coordinator of this site? Confirm its status
BoiseUnited StatesRecruiting
WBMD Pediatrics
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
UNC Children's Hospital
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Chapel HillUnited StatesRecruiting
University of Illinois at Chicago
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ChicagoUnited StatesRecruiting
Childrens Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Cleveland Clinic Childrens Outpatient Center
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ClevelandUnited StatesRecruiting
Prisma Health Pediatric Endocrinology
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ColumbiaUnited StatesRecruiting
Centricity Research Columbus Endocrinology
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ColumbusUnited StatesRecruiting
Research Institute Of Dallas
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DallasUnited StatesRecruiting
Children's Hospital of Colorado
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DenverUnited StatesNot yet recruiting
Prisma Health Midlands
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GreenvilleUnited StatesRecruiting
UT Health Houston
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HoustonUnited StatesRecruiting
Texas Childrens Hospital
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HoustonUnited StatesRecruiting
Cohen Children's Medical Center Division of Pediatric Endocrinology
Coordinator of this site? Confirm its status
Hyde ParkUnited StatesRecruiting
Center for Diabetes and Metabolic Diseases Indiana University
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IndianapolisUnited StatesRecruiting
University of Iowa Stead Family Children's Hospitals
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Iowa CityUnited StatesRecruiting
University of Mississippi Medical Center
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JacksonUnited StatesRecruiting
Nemours Children's Health
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JacksonvilleUnited StatesRecruiting
Arkansas Childrens Hospital
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Little RockUnited StatesRecruiting
UCLA Mattel Children's Hospital
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Los AngelesUnited StatesRecruiting
Division of Endocrinology, Diabetes, and Metabolism
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Los AngelesUnited StatesRecruiting
Norton Children's Endocrinology
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LouisvilleUnited StatesRecruiting
D&H National Research Centers, Inc
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MiamiUnited StatesRecruiting
Children's Wisconsin - Milwaukee Campus
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MilwaukeeUnited StatesRecruiting
Yale Diabetes Research
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New HavenUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
AdventHealth Orlando
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OrlandoUnited StatesRecruiting
St Christophers Hospital For Children
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PhiladelphiaUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
University of Utah
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Salt Lake CityUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
SUNY Upstate Medical University
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SyracuseUnited StatesRecruiting
D&H Tamarac Research Center, LLC
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TamaracUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting
University of Arizona
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TucsonUnited StatesRecruiting
Children's National Medical Center
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Washington D.C.United StatesRecruiting
Emerson Clinical Research Institute
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.