Recruiting
Phase 3

Orforglipron vs. Dulaglutide

Sponsor:

Eli Lilly and Company

Code:

NCT07668336

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Dulaglutide

Study Details

Brief summary:

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.

Participation in the study will last about 61 weeks.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07668336

Start date

Jul 8, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
  • Have HbA1c > 6.5% to ≤ 11.0% at screening
  • Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of >85th percentile

Exclusion Criteria:

  • Have type 1 diabetes
  • After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
  • Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening
  • Have a history of pancreatitis or gallbladder disease
  • Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening
  • Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron

Participants will receive orforglipron orally

active comparator: Dulaglutide

Participants will receive dulaglutide subcutaneously (SC)

Interventions

Orforglipron

Administered orally

Dulaglutide

Administered SC

Primary outcome measure

  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Stamford Therapeutics Consortium

Recruiting

Stamford, Connecticut, United States, 06905

Principal Investigator:

David Radin

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

4045371281

Principal Investigator:

Kimball Johnson

Medical Research Partners

Recruiting

Ammon, Idaho, United States, 83406

Contacts

(208) 522-4600

Principal Investigator:

Mitchael Steorts

Cotton O'Neil Diabetes & Endocrinology

Recruiting

Topeka, Kansas, United States, 66606

Contacts

785-354-9591

Principal Investigator:

susan brian

Advantage Clinical Trials

Recruiting

The Bronx, New York, United States, 10467

Contacts

917-962-0234

Principal Investigator:

Giancarlo Guido

Central States Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

918-645-5400

Principal Investigator:

Sarah Land

Frontier Clinical Research, LLC

Recruiting

Smithfield, Pennsylvania, United States, 15478

Contacts

7245698036

Principal Investigator:

Marcy Goisse

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

Contacts

409-331-6040

Principal Investigator:

John Fowler

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

3617397250

Principal Investigator:

Ana Paez

Proactive Clinical Research LLC

Recruiting

Edinburg, Texas, United States, 78539

Contacts

956-731-1260

Principal Investigator:

Gerardo Orfanos

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

210-545-4900

Principal Investigator:

Michelle Welch

Victoria Clinical Research Group

Recruiting

Victoria, Texas, United States, 77901

Contacts

3612107869

Principal Investigator:

John Clinton

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Pediatric trial
  • GLP-1 receptor agonist
  • Oral GLP-1
  • Small molecule GLP-1
  • Youth-onset type 2 diabetes
  • Glycemic control
  • Continuous glucose monitoring
  • Non-inferior
  • Active-controlled

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.