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

August 6, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425
        • Recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Principal Investigator:
          • Evelyn Blanc
        • Contact:
          • Phone Number: 011 4804-6669
      • Mar del Plata, Argentina, B7600FYK
        • Not yet recruiting
        • Centro de Investigaciones Medicas Mar del Plata
        • Contact:
          • Phone Number: 0223 4917628
        • Principal Investigator:
          • Mariela Colantonio
      • Rosario, Argentina, 2000
        • Recruiting
        • INECO Neurociencias Oroño
        • Principal Investigator:
          • María Cappiello
        • Contact:
          • Phone Number: +54 9 3417 56-7348
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
        • Contact:
          • Phone Number: +5493815455588
        • Principal Investigator:
          • Ana Fernandez Alonso
      • San Nicolás, Argentina, 2900
        • Recruiting
        • Go Centro Medico San Nicolas
        • Principal Investigator:
          • Paulina Lanchiotti
        • Contact:
          • Phone Number: +5493364281994
  • Mexico
      • Ciudad Madero, Mexico, 89440
        • Not yet recruiting
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
        • Principal Investigator:
          • Rafael Violante Ortiz
        • Contact:
          • Phone Number: 833 126 0055
      • Puebla City, Mexico, 72190
        • Not yet recruiting
        • Hospital Angeles (HA) - Puebla
        • Principal Investigator:
          • Margarita Barrientos
        • Contact:
          • Phone Number: 222 303 8350
      • Tampico, Mexico, 89210
        • Not yet recruiting
        • Clínica Cemain
        • Contact:
          • Phone Number: 833 343 0717
        • Principal Investigator:
          • Ricardo Salas Flores
      • Tlalpan, Mexico, 14090
        • Not yet recruiting
        • Innovacion y Desarrollo de Estrategias en Salud SA de CV
        • Principal Investigator:
          • Maria Fernanda Castilla Peon
      • Veracruz, Mexico, 91910
        • Not yet recruiting
        • Arké SMO S.A de C.V
        • Contact:
          • Phone Number: 2299314102
        • Principal Investigator:
          • Maria del Carmen Ramon Ramirez
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
          • Phone Number: 520-626-3197
        • Principal Investigator:
          • Sunil Sinha
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3500
        • Recruiting
        • Arkansas Childrens Hospital
        • Contact:
          • Phone Number: 505-272-5551
        • Principal Investigator:
          • Jon Oden
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Mattel Children's Hospital
        • Contact:
          • Phone Number: 310-203-7631
        • Principal Investigator:
          • Vibha Singhal
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Division of Endocrinology, Diabetes, and Metabolism
        • Principal Investigator:
          • Lily Chao
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Phone Number: 415-514-6234
        • Principal Investigator:
          • Shylaja Sirinivasan
    • Colorado
      • Denver, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital of Colorado
        • Principal Investigator:
          • Melanie Cree
        • Contact:
          • Phone Number: 20-777-3618
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Diabetes Research
        • Contact:
          • Phone Number: 203-737-7177
        • Principal Investigator:
          • Michelle Van Name
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
          • Phone Number: 888-884-2327
        • Principal Investigator:
          • Shideh Majidi
      • Washington D.C., District of Columbia, United States, 20009
        • Recruiting
        • Emerson Clinical Research Institute
        • Contact:
          • Phone Number: 202-239-0777
        • Principal Investigator:
          • Julia Pineda
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Health
        • Principal Investigator:
          • Camila Pereira-Eshraghi
      • Miami, Florida, United States, 33155
        • Recruiting
        • D&H National Research Centers, Inc
        • Contact:
          • Phone Number: 786-375-6210
        • Principal Investigator:
          • Yanetsi Flores Landa
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
          • Phone Number: 407-896-2901
        • Principal Investigator:
          • Konda Reddy
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • D&H Tamarac Research Center, LLC
        • Contact:
          • Phone Number: 786-375-6210
        • Principal Investigator:
          • Helena Gaviria
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Henry Rodriguez
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
        • Principal Investigator:
          • Daniel Hsia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Centricity Research Columbus Endocrinology
        • Principal Investigator:
          • Steven Leichter
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Children's Endocrinology and Diabetes
        • Contact:
          • Phone Number: 208-381-7340
        • Principal Investigator:
          • Daniel Flynn
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
          • Phone Number: 312-307-9385
        • Principal Investigator:
          • Roxana Aguirre Castaneda
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Center for Diabetes and Metabolic Diseases Indiana University
        • Principal Investigator:
          • Tamara Hannon
        • Contact:
          • Phone Number: 317-278-9699
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Stead Family Children's Hospitals
        • Principal Investigator:
          • Michael Tansey
        • Contact:
          • Phone Number: 319-335-0077
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Endocrinology
        • Contact:
          • Phone Number: 502-588-3400
        • Principal Investigator:
          • Sara Watson
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University School Of Medicine
        • Principal Investigator:
          • Risa Wolf
        • Contact:
          • Phone Number: 443-287-9032
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Nazmin Dixit
        • Contact:
          • Phone Number: 601-815-5000
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Hospital
        • Contact:
          • Phone Number: 505-272-3073
        • Principal Investigator:
          • Michelle Hutchison
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • WBMD Pediatrics
        • Principal Investigator:
          • Kathleen Bethin
      • Hyde Park, New York, United States, 11042
        • Recruiting
        • Cohen Children's Medical Center Division of Pediatric Endocrinology
        • Contact:
          • Phone Number: 516-472-3750
        • Principal Investigator:
          • Benjamin Nwosu
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
          • Phone Number: 315-464-9006
        • Principal Investigator:
          • David Hansen
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Children's Hospital
        • Contact:
          • Phone Number: 919-966-2333
        • Principal Investigator:
          • Nina Jain
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Childrens Hospital Medical Center
        • Contact:
          • Phone Number: 513-803-7274
        • Principal Investigator:
          • Ryan Brady
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Childrens Outpatient Center
        • Contact:
          • Phone Number: 216-636-2828
        • Principal Investigator:
          • Roy Kim
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
          • Phone Number: 405-271-6764
        • Principal Investigator:
          • Jeanie Tryggestad
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Steven Willi
      • Philadelphia, Pennsylvania, United States, 19134
        • Recruiting
        • St Christophers Hospital For Children
        • Contact:
          • Phone Number: 215-427-7911
        • Principal Investigator:
          • Elizabeth Suarez
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Pediatric Endocrinology
        • Contact:
          • Phone Number: 803-434-7990
        • Principal Investigator:
          • Alison Lunsford
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Midlands
        • Contact:
          • Phone Number: 864-454-5656
        • Principal Investigator:
          • Elaine Apperson
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Research Institute of Dallas
        • Principal Investigator:
          • Heidi Shea
        • Contact:
          • Phone Number: 248-817-4331
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
          • Phone Number: 713-500-7257
        • Principal Investigator:
          • Anvi Shah
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Childrens Hospital
        • Principal Investigator:
          • Siripoom McKay
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Jacqueline Chan
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Phone Number: 206-987-3897
        • Principal Investigator:
          • Petter Bjornstand
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin - Milwaukee Campus
        • Contact:
          • Phone Number: 414-955-8486
        • Principal Investigator:
          • Susanne Cabrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through Week 26
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 26
Baseline, Week 26
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
Time Frame: Predose through Week 30
Predose through Week 30
PK: Maximum Observed Concentration (Cmax) of Dulaglutide
Time Frame: Predose through Week 30
Predose through Week 30
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline in the EQ-5D-Y-5L
Time Frame: Baseline, Week 26
Baseline, Week 26
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)
Time Frame: Baseline, Week 26
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27198
  • H9X-MC-GBGS (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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