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New daily pill could help teens manage type 2 diabetes

NCT ID NCT07668336

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests a new once-daily oral pill called orforglipron against a weekly injection (dulaglutide) in 170 teens aged 10-18 with type 2 diabetes. The goal is to see if the pill works better at controlling blood sugar and is safe. Participants will be followed for about 61 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
orforglipron (oral pill)
What this could lead to
If it works, this could offer a convenient once-daily pill option for teens with type 2 diabetes, potentially improving blood sugar control and weight management.
What could go wrong
This is a phase 3 trial, but it's still early for this age group. The drug may not work better than existing options, and side effects like nausea or hypoglycemia are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advantage Clinical Trials

    The Bronx, New York, 10467, United States

  • Alder Hey Children's Hospital

    Liverpool, L14 5AB, United Kingdom

  • All India Institute of Medical Sciences

    Bhubaneswar, 751019, India

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

  • Avron Hospitals

    Ahmedabad, 380013, India

  • Azienda Ospedaliera Universitaria Di Messina G. Martino

    Messina, 98125, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, 50139, Italy

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • Cendi - Endocrinologia e Diabetes

    Goiânia, 74230-035, Brazil

  • Central States Research

    Tulsa, Oklahoma, 74136, United States

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

    Ciudad Madero, 89440, Mexico

  • Centro de Investigacion Medica de Occidente, S.C.

    Guadalajara, 44260, Mexico

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803, Brazil

  • Centro de investigación y control metabólico

    Monterrey, 66465, Mexico

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)

    Atlanta, Georgia, 30329, United States

  • China Medical University Hospital

    Taichung, 404332, Taiwan

  • Chungnam national university hospital

    Junggu, 35015, South Korea

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica García Flores SC

    Monterrey, 64610, Mexico

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606, United States

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411, United States

  • Endolife Speciality Hospitals

    Guntur, 522001, India

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478, United States

  • Fukuoka Children's Hospital

    Fukuoka, 813-0017, Japan

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • Gujarat Endocrin Pvt Ltd

    Ahmedabad, 380052, India

  • H.R.U Málaga - Hospital General

    Málaga, 29011, Spain

  • Harmony Health Hub

    Nashik, 422002, India

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hull Royal Infirmary

    Hull, HU3 2JZ, United Kingdom

  • IBTED - Tecnologia e Educação em Diabetes

    São Paulo, 04038-032, Brazil

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147, Italy

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, 99010-120, Brazil

  • Instituto da Crianca com Diabetes

    Porto Alegre, 91350-250, Brazil

  • Instituto de Pesquisa Clinica

    São Paulo, 01223-001, Brazil

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080, Brazil

  • Jawaharlal Nehru Medical College

    Aligarh, 202002, India

  • Juntendo University Urayasu Hospital

    Urayasu, 279-0021, Japan

  • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

    Mumbai, 400012, India

  • Kyungpook National University Chilgok Hospital

    Deagu, 41404, South Korea

  • Medical Research Partners

    Ammon, Idaho, 83406, United States

  • Nihon University Hospital

    Chiyoda-ku, 101-8309, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Ospedale Pediatrico Salesi

    Ancona, 60123, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Proactive Clinical Research LLC

    Edinburg, Texas, 78539, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Royal London Hospital

    London, E1 1BB, United Kingdom

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saitama City Hospital

    Saitama, 336-8522, Japan

  • Saitama Medical University Hospital

    Iruma, 350-0495, Japan

  • Sendai City Hospital - Asutonagamachi

    Sendai, 982-8502, Japan

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shiga General Hospital

    Moriyama, 524-8524, Japan

  • Shizuoka Children's Hospital

    Shizuoka, 420-8660, Japan

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, 14584, South Korea

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905, United States

  • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

    Sacramento, California, 95821, United States

  • UBAM Unidad Biomedica Avanzada Monterrey

    Monterrey, 64460, Mexico

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Naples Federico II

    Naples, 80131, Italy

  • Urakami Pediatric Endocrinology and Diabetes Clinic

    Tokyo, 101-0062, Japan

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37204, United States

  • Victoria Clinical Research Group

    Victoria, Texas, 77901, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.