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Phase 3 Study of Oral Orforglipron vs Weekly Dulaglutide in Children and Adolescents (10‑<18 years) with Type 2 Diabetes

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on children and teenagers aged 10 to under 18 who have Type 2 Diabetes. It compares an oral medication called Orforglipron, taken as a daily capsule, with a weekly injectable medicine named Dulaglutide. The main goal is to see if Orforglipron can control blood sugar at least as well as Dulaglutide.

Participants will be assigned to receive either the daily capsule or the weekly injection for several months. Blood tests will be done at the start and during the study to measure changes in hemoglobin A1c, which reflects average blood sugar levels over the past few weeks. The study will also monitor safety by checking for any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and enrollment
After you are accepted into the study, baseline measurements such as blood sugar level and hemoglobin a1c will be taken.
These measurements are used to compare later results with the starting values.
Step 2
Start of study medication
If you are assigned to the test group, you will take one orforglipron capsule containing 36 mg once each day by mouth.
If you are assigned to the comparator group, you will receive a dulaglutide injection of 1.5 mg once each week; subcutaneous means the injection is given under the skin.
Step 3
Regular follow‑up visits
You will attend clinic visits at intervals determined by the study staff to have your blood tests, vital signs, and any side effects recorded.
The study staff will check the amount of medication you have taken and may adjust the schedule if needed.
Step 4
Continuous safety monitoring
Throughout the study you may be asked to report any new symptoms, and the study team will evaluate the safety of the medication.
Step 5
Final study visit and assessment
At the end of the study period, the same measurements taken at baseline, including hemoglobin a1c, will be repeated to determine the effect of the medication.
The study will then be closed for each participant.

Who can join the trial?

6 criteria

You must have type 2 diabetes that is being treated with diet and exercise and with the medication metformin and/or a long‑acting insulin called basal insulin.
Your screening blood test called HbA1c must be greater than 6.5% but not higher than 11.0%.
You need to weigh at least 50 kilograms (about 110 pounds) and have a body mass index (BMI) that is above the 85th percentile for your age and sex.
Both men and women are eligible to join the study.
You must be an adult (generally 18 years of age or older).
The study may also include participants who are considered vulnerable, such as older adults or those with limited decision‑making capacity.

Who cannot join the trial?

7 criteria

Having type 1 diabetes (a form of diabetes that usually starts in childhood and requires insulin)
After being diagnosed with type 2 diabetes, having ever had diabetic ketoacidosis (a serious condition where the body builds up acids called ketones) or hyperosmolar syndrome (a dangerous high‑blood‑sugar emergency)
Having at least one episode of severe low blood sugar that needed help from another person, or not feeling the warning signs of low blood sugar (hypoglycemic unawareness) in the past 6 months
Having a past history of pancreatitis (inflammation of the pancreas) or any disease of the gallbladder (the organ that stores bile)
Having you or a close family member who has had medullary thyroid cancer (a rare thyroid tumor) or multiple endocrine neoplasia type 2 (MEN2) (a genetic condition that can cause tumors in several glands)
Having taken any diabetes medicine other than metformin, long‑acting insulin (basal insulin), or a class called SGLT2 inhibitors in the 90 days before screening
Having used prescription or over‑the‑counter drugs that are meant to help lose weight in the 90 days before screening

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universita' Degli Studi Di Verona
Responsive
Verona, Italy
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Orforglipron
is an experimental oral medication taken as a capsule once a day. In this study it is being tested to see if it can lower blood sugar in teenagers with type 2 diabetes. Researchers are looking at how well it works, how safe it is, and how the body processes it compared with a standard treatment.
Dulaglutide
is an approved diabetes medicine that is given by injection once a week. It belongs to a class of drugs that help the pancreas release more insulin and reduce the amount of sugar released by the liver. In this trial it is used as the comparison treatment to see if the new oral drug works at least as well as this established therapy.

Dulaglutide

What is already known about the treatment

Orforglipron
This medication is taken as a 36 mg oral capsule taken once daily. It is currently an investigational drug being studied in clinical trials and is not yet approved for general medical use. Orforglipron is being tested for the treatment of type 2 diabetes in children and adolescents. It works by activating the GLP‑1 receptor, which helps the pancreas release more insulin after meals and can lower blood sugar, and it belongs to the class of oral GLP‑1 receptor agonists.
Dulaglutide
Dulaglutide is given as a once‑weekly subcutaneous injection using a pre‑filled pen. It is an approved medication that is widely used to treat type 2 diabetes in adults and now being compared in pediatric studies. The drug mimics the natural hormone GLP‑1, stimulating insulin release, reducing glucose production, and slowing stomach emptying to improve blood sugar control. It is classified as an injectable GLP‑1 receptor agonist.

Investigated diseases

Diabetes mellitus, type 2 - Type 2 diabetes is a chronic condition in which the body does not use insulin properly. It usually begins with insulin resistance, where cells respond less to the hormone. Over time the pancreas may produce less insulin as it becomes overworked. Blood sugar levels rise gradually and remain higher than normal. If the high sugar persists, damage can develop in blood vessels, nerves, and organs. The disease often progresses slowly and may require ongoing monitoring.