A Phase 3 interventional study of Orforglipron and Dulaglutide in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Recruiting at 71 sites in 11 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 170 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive dulaglutide subcutaneously (SC)
Drug: Dulaglutide
Administered orally
Also known as: LY3502970
Administered SC
Also known as: LY2189265
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
Change from Baseline in HbA1c
Time frame: Baseline, Week 52
Percentage of Participants with HbA1c ≤6.5%
Time frame: Week 40
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 40
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL
Time frame: Baseline, during 2 weeks prior to Week 40
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 40
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 40
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 40
Change from Baseline in Tanner Staging
Time frame: Baseline, Week 52
Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)
Time frame: Baseline, Week 40
Change from Baseline in the EQ-5D-Y-5L
Time frame: Baseline, Week 40
Number of Participants by Acceptability Response Category
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
Time frame: Predose through Week 30
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Orforglipron