Not yet recruitingPHASE3INTERVENTIONAL

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

This research study is about a new medicine called orforglipron for young people, aged 10 to 17, who have type 2 diabetes. We want to find out how well this new medicine works compared to another common medicine for type 2 diabetes, called dulaglutide. The study will also carefully check if the medicines are safe to use and how the body handles them. Taking part in this study would involve regular check-ups and last for about 61 weeks, which is just over a year. The main goal is to find better ways to help young people manage their type 2 diabetes.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

170

Start

01 Sep 2026

Estimated completion

01 Mar 2030

Diabetes Mellitus, Type 2

What is this study about?

Type 2 diabetes is a condition where your body doesn't use sugar properly, leading to high blood sugar levels. It's often managed with diet, exercise, and medicines. This study focuses on young people, aged between 10 and 17 years old, who have type 2 diabetes. We are particularly interested in a new medicine called orforglipron. We want to learn if it's an effective and safe treatment option for this age group.

To understand how well orforglipron works, we're comparing it to another medicine, dulaglutide, which is already used for type 2 diabetes. The study will look closely at how these medicines affect blood sugar levels, if they have any side effects, and how they behave inside the body. Your involvement could help doctors understand more about treating type 2 diabetes in young people.

The information gathered from this study is really important. It helps healthcare professionals decide on the best treatments for young people with type 2 diabetes now and in the future. By participating, you could contribute to medical knowledge and potentially help many others facing similar challenges.

Key takeaways

This study is testing a new medicine for young people aged 10-17 with type 2 diabetes.
It compares the new medicine (orforglipron) with an existing one (dulaglutide).
The study lasts about 61 weeks and involves regular clinic visits.
Participation helps future medical understanding of type 2 diabetes in young people.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, participants must be between 10 and 17 years old and have type 2 diabetes. You would need to be managing your diabetes with diet and exercise, and also be taking metformin and/or a type of insulin called basal insulin. Your recent blood test (HbA1c) should show your average blood sugar levels are between 6.5% and 11.0%. Also, you should weigh at least 50 kilograms (about 7 stone 12 pounds) and have a body mass index (BMI) that's considered higher for your age.

There are also some reasons why you might not be able to join. For example, if you have type 1 diabetes instead of type 2, or if you've had severe problems like diabetic ketoacidosis (a serious complication of diabetes) in the past. If you've had issues with very low blood sugar that you couldn't feel (hypoglycemic unawareness) or severe low blood sugar recently, you wouldn't be able to take part.

Other reasons for not being able to join include a history of certain conditions like pancreatitis or gallbladder disease, or a personal or family history of specific types of thyroid cancer. Also, if you've taken certain other diabetes medicines or weight-loss drugs within the last 3 months, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 10 and 17 years old?
Do you have type 2 diabetes?
Are you currently taking metformin and/or basal insulin?
Do you weigh at least 50 kilograms (about 7 stone 12 pounds)?
Have you *not* had severe low blood sugar or an inability to feel low blood sugar recently?
Do you have no history of certain conditions like pancreatitis or specific thyroid cancers?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for about 61 weeks, which is just over a year. During this time, you will have regular visits to the clinic for health check-ups and assessments. These visits will help us monitor your health, how the medicine is working, and if you have any side effects.

You'll be given either the new medicine, orforglipron, or the existing medicine, dulaglutide, to take regularly as instructed. There will be blood tests and other examinations to see how your body is responding to the treatment. You'll also be asked to keep track of certain information at home.

Throughout the study, the research team will be there to support you and answer any questions you have. Even if you join, you are always free to decide to leave the study at any time, for any reason, without it affecting your medical care.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new or existing medicine for your type 2 diabetes and having close medical monitoring. However, there are also potential risks, including possible side effects from the medicines. The research team will explain all known risks to you before you agree to participate. You have the right to withdraw from the study at any time without having to give a reason, and this decision will not affect your usual medical care.

Locations (71)

Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Verified postcode
Sacramento, United States
Rady Children's Hospital
Verified postcode
San Diego, United States
Stamford Therapeutics Consortium
Verified postcode
Stamford, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)
Verified postcode
Atlanta, United States
CenExel iResearch, LLC
Verified postcode
Decatur, United States
Medical Research Partners
Verified postcode
Ammon, United States
Cotton O'Neil Diabetes & Endocrinology
Verified postcode
Topeka, United States
SUNY Upstate Medical University
Verified postcode
Syracuse, United States
Advantage Clinical Trials
Verified postcode
The Bronx, United States
Central States Research
Verified postcode
Tulsa, United States
Frontier Clinical Research, LLC
Verified postcode
Smithfield, United States
Vanderbilt Health One Hundred Oaks
Verified postcode
Nashville, United States

Common questions

What is Type 2 Diabetes?

Type 2 diabetes is a condition where your body struggles to use sugar (glucose) for energy properly, leading to high sugar levels in your blood.

What is an 'HbA1c' blood test?

HbA1c is a simple blood test that shows your average blood sugar levels over the past 2 to 3 months. It's a common way to see how well diabetes is being managed.

What does 'Phase 3' mean for a study?

Phase 3 means the medicine has already been tested in smaller groups and is now being studied in a larger group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments.

Will I know if I'm getting the new medicine or the existing one?

In many studies like this, participants are randomly assigned to receive one of the medicines, and sometimes neither you nor the doctors know which one you are getting. This helps make the study as fair as possible.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your regular medical care. Your decision will be fully respected.

How to find out more

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

lillytrials@lilly.com 317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.