Type 2 DiabetesPhase 3NCT06739122
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 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 51 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 51 sitesin 3 countries
- Study dates
- 10 Jan 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
51 sites in 3 countries
United States41 sites, 41 recruiting
- Recruiting
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
505-272-3073
Michelle Hutchison
- Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
Daniel Hsia
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
443-287-9032
Risa Wolf
- Recruiting
St. Luke's Children's Endocrinology and Diabetes
Boise, Idaho, 83712
208-381-7340
Daniel Flynn
- Recruiting
WBMD Pediatrics
Buffalo, New York, 14203
Kathleen Bethin
- Recruiting
UNC Children's Hospital
Chapel Hill, North Carolina, 27514
919-966-2333
Nina Jain
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
312-307-9385
Roxana Aguirre Castaneda
- Recruiting
Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
513-803-7274
Ryan Brady
- Recruiting
Cleveland Clinic Childrens Outpatient Center
Cleveland, Ohio, 44106
216-636-2828
Roy Kim
- Recruiting
Prisma Health Pediatric Endocrinology
Columbia, South Carolina, 29203
803-434-7990
Alison Lunsford
- Recruiting
Centricity Research Columbus Endocrinology
Columbus, Georgia, 31904
Steven Leichter
- Recruiting
Research Institute of Dallas
Dallas, Texas, 75231
248-817-4331
Heidi Shea
- Not yet recruiting
Children's Hospital of Colorado
Denver, Colorado, 80045
20-777-3618
Melanie Cree
- Recruiting
Prisma Health Midlands
Greenville, South Carolina, 29615
864-454-5656
Elaine Apperson
- Recruiting
Texas Childrens Hospital
Houston, Texas, 77030
Siripoom McKay
- Recruiting
UT Health Houston
Houston, Texas, 77030
713-500-7257
Anvi Shah
- Recruiting
Cohen Children's Medical Center Division of Pediatric Endocrinology
Hyde Park, New York, 11042
516-472-3750
Benjamin Nwosu
- Recruiting
Center for Diabetes and Metabolic Diseases Indiana University
Indianapolis, Indiana, 46202
317-278-9699
Tamara Hannon
- Recruiting
University of Iowa Stead Family Children's Hospitals
Iowa City, Iowa, 52242
319-335-0077
Michael Tansey
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
601-815-5000
Nazmin Dixit
- Recruiting
Nemours Children's Health
Jacksonville, Florida, 32207
Camila Pereira-Eshraghi
- Recruiting
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202-3500
505-272-5551
Jon Oden
- Recruiting
Division of Endocrinology, Diabetes, and Metabolism
Los Angeles, California, 90027
Lily Chao
- Recruiting
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
310-203-7631
Vibha Singhal
- Recruiting
Norton Children's Endocrinology
Louisville, Kentucky, 40202
502-588-3400
Sara Watson
- Recruiting
D&H National Research Centers, Inc
Miami, Florida, 33155
786-375-6210
Yanetsi Flores Landa
- Recruiting
Children's Wisconsin - Milwaukee Campus
Milwaukee, Wisconsin, 53226
414-955-8486
Susanne Cabrera
- Recruiting
Yale Diabetes Research
New Haven, Connecticut, 06511
203-737-7177
Michelle Van Name
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
405-271-6764
Jeanie Tryggestad
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
407-896-2901
Konda Reddy
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Steven Willi
- Recruiting
St Christophers Hospital For Children
Philadelphia, Pennsylvania, 19134
215-427-7911
Elizabeth Suarez
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Jacqueline Chan
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
415-514-6234
Shylaja Sirinivasan
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
206-987-3897
Petter Bjornstand
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
315-464-9006
David Hansen
- Recruiting
D&H Tamarac Research Center, LLC
Tamarac, Florida, 33321
786-375-6210
Helena Gaviria
- Recruiting
University of South Florida
Tampa, Florida, 33612
Henry Rodriguez
- Recruiting
University of Arizona
Tucson, Arizona, 85724
520-626-3197
Sunil Sinha
- Recruiting
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009
202-239-0777
Julia Pineda
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
888-884-2327
Shideh Majidi
Argentina5 sites, 5 recruiting
- Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425
011 4804-6669
Evelyn Blanc
- Not yet recruiting
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, B7600FYK
0223 4917628
Mariela Colantonio
- Recruiting
INECO Neurociencias Oroño
Rosario, 2000
+54 9 3417 56-7348
María Cappiello
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, T4000IHE
+5493815455588
Ana Fernandez Alonso
- Recruiting
Go Centro Medico San Nicolás
San Nicolás, 2900
+5493364281994
Paulina Lanchiotti
Mexico5 sites, 5 recruiting
- Not yet recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, 89440
833 126 0055
Rafael Violante Ortiz
- Not yet recruiting
Hospital Angeles (HA) - Puebla
Puebla City, 72190
222 303 8350
Margarita Barrientos
- Not yet recruiting
Clínica Cemain
Tampico, 89210
833 343 0717
Ricardo Salas Flores
- Not yet recruiting
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Tlalpan, 14090
Maria Fernanda Castilla Peon
- Not yet recruiting
Arké SMO S.A de C.V
Veracruz, 91910
2299314102
Maria del Carmen Ramon Ramirez
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Dulaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called LY2189265
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide | Experimental | Participants will receive dulaglutide subcutaneously (SC) Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
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
Measured: Baseline through Week 26
Secondary outcomes (7)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
Measured: Predose through Week 30
PK: Maximum Observed Concentration (Cmax) of Dulaglutide
Measured: Predose through Week 30
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 26
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 26
Change from Baseline in Total Cholesterol
Measured: Baseline, Week 26
Change from Baseline in the EQ-5D-Y-5L
Measured: Baseline, Week 26
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739122
- Sponsor's protocol ID
- 27198
- Other IDs
- H9X-MC-GBGS
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06739122
- Acronym / sponsor ID
- 27198
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide | Experimental | Drug: DulaglutideParticipants will receive dulaglutide subcutaneously (SC) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideAlso: LY2189265Administered SC | Drug | Dulaglutide |
Primary outcome
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
7 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
Time frame: Predose through Week 30
PK: Maximum Observed Concentration (Cmax) of Dulaglutide
Time frame: Predose through Week 30
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 26
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 26
Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 26
Change from Baseline in the EQ-5D-Y-5L
Time frame: Baseline, Week 26
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)
Time frame: Baseline, Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants with Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 51 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Argentina, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.