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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita Degli Studi Di Messina	Messina	Italy
Alidezd Ojldougtaer Ufqknnvbidlnu Oaqztvvb Rfboxhv Unjgfya I G M Lviwgzp G Slreyn	Ancona	Italy
Uufovfefmsniyczrk Deerp Sxodq Dt Viusrj	Verona	Italy
Asprktv Oicdlsjeizp Ufbqihhuhvqpa Fvplamqz Ir Dj Nbcdws	Naples	Italy
Iuwne Iwvrecpt Gfwwghnp Gyaexsd	Genoa	Italy
Aykuprq Ogfbgtnnyna Ugzbxozfhcvlg Mndaj Irzwu	Florence	Italy
Ubetznkikulg Zglwrtryua Gzfj	Gent	Belgium
Sjqbj Lmj	Brussels	Belgium
Hcktnuwv Vgja dnpjkjpn	Barcelona	Spain
Vzfjxc dhd Ruvic Uhovqwprey Hyjjbmfe	Sevilla	Spain
Hxbzurqy Uurlbsblqvubk Rhqpamfi Db Mbhmva	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	28.09.2026
Italy	Not yet recruiting	28.09.2026
Spain	Not yet recruiting	28.09.2026

Trial locations

Investigated Drugs:

Dulaglutide

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.

Investigated Diseases:

Type 2 diabetes mellitus

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.

Trial ID:

2025-524811-35-00

Protocol code:

J2A-MC-GZGY

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?