A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

  • Dulaglutide

    Drug

    Administered SC

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: OrforglipronExperimental treatment 1 intervention
Group B: DulaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame
Baseline, Week 40

Secondary outcomes

1

Change from Baseline in HbA1c

Time frame
Baseline, Week 52
2

Percentage of Participants with HbA1c ≤6.5%

Time frame
Week 40
3

Percent Change from Baseline in Body Mass Index (BMI)

Time frame
Baseline, Week 40
4

Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL

Time frame
Baseline, during 2 weeks prior to Week 40

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: