Diabetes Mellitus, Type 2Phase 3ACHIEVE-PEDSNCT07668336
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
A Phase 3 study testing Orforglipron and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 71 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Orforglipron and Dulaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 71 sitesin 11 countries
- Study dates
- 8 Jul 2026to Mar 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
71 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
71 sites in 11 countries
United States17 sites, 17 recruiting
- Recruiting
Medical Research Partners
Ammon, Idaho, 83406
(208) 522-4600
Mitchael Steorts
- Not yet recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)
Atlanta, Georgia, 30329
2257632831
Daniel Hsia
- Recruiting
Gadolin Research
Beaumont, Texas, 77702
409-331-6040
John Fowler
- Recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
3617397250
Ana Paez
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
4045371281
Kimball Johnson
- Recruiting
Proactive Clinical Research LLC
Edinburg, Texas, 78539
956-731-1260
Gerardo Orfanos
- Not yet recruiting
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204
Jennifer Kelley
- Not yet recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, 95821
9164261902
Gnanagurudasan Prakasam
- Not yet recruiting
Rady Children's Hospital
San Diego, California, 92123
8589668940
Carla Demeterco-Berggren
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
- Recruiting
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
7245698036
Marcy Goisse
- Recruiting
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
David Radin
- Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
315-464-9006
David Hansen
- Recruiting
Advantage Clinical Trials
The Bronx, New York, 10467
917-962-0234
Giancarlo Guido
- Recruiting
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
785-354-9591
susan brian
- Recruiting
Central States Research
Tulsa, Oklahoma, 74136
918-645-5400
Sarah Land
- Recruiting
Victoria Clinical Research Group
Victoria, Texas, 77901
3612107869
John Clinton
Japan11 sites, 11 recruiting
- Not yet recruiting
Nihon University Hospital
Chiyoda-ku, 101-8309
81120023812
Junichi Suzuki
- Recruiting
Fukuoka Children's Hospital
Fukuoka, 813-0017
81120023812
Kenichi Miyako
- Not yet recruiting
Saitama Medical University Hospital
Iruma, 350-0495
81120023812
Toru Kikuchi
- Recruiting
Shiga General Hospital
Moriyama, 524-8524
81120023812
Katsuyuki Matsui
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
81120023812
Yohei Ogawa
- Recruiting
Osaka City General Hospital
Osaka, 534-0021
81120023812
Jun Mori
- Recruiting
Saitama City Hospital
Saitama, 336-8522
81120023812
Masayuki Akashi
- Recruiting
Sendai City Hospital - Asutonagamachi
Sendai, 982-8502
81120023812
Ikuma Fujiwara
- Recruiting
Shizuoka Children's Hospital
Shizuoka, 420-8660
81120023812
Shinichiro Sano
- Recruiting
Urakami Pediatric Endocrinology and Diabetes Clinic
Tokyo, 101-0062
81120023812
Tatsuhiko Urakami
- Not yet recruiting
Juntendo University Urayasu Hospital
Urayasu, 279-0021
81120023812
Hiroaki Satoh
India8 sites, 8 recruiting
- Not yet recruiting
Avron Hospitals
Ahmedabad, 380013
079 66 200480
Tiven Marwah
- Not yet recruiting
Gujarat Endocrin Pvt Ltd
Ahmedabad, 380052
91-9824042688
parag Shah
- Not yet recruiting
Jawaharlal Nehru Medical College
Aligarh, 202002
Hamid Ashraf
- Not yet recruiting
All India Institute of Medical Sciences
Bhubaneswar, 751019
0674-2476789
Kishore Behera
- Not yet recruiting
Endolife Speciality Hospitals
Guntur, 522001
9849945577
Kongara Srikanth
- Not yet recruiting
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, 400012
Manjiri Karlekar
- Not yet recruiting
Harmony Health Hub
Nashik, 422002
Tushar Godbole
- Not yet recruiting
All India Institute of Medical Sciences
New Delhi, 110029
91-11-26593237
Rajesh Khadgawat
Brazil7 sites, 7 recruiting
- Not yet recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
55 19 3267 0023
Sylka Rodovalho
- Not yet recruiting
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
55 19 3343-8688
Mila Cunha
- Not yet recruiting
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035
5562992240229
Nelson Rassi
- Not yet recruiting
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120
55 54 3581 1831
Hugo Kurtz Lisboa
- Not yet recruiting
Instituto da Crianca com Diabetes
Porto Alegre, 91350-250
55133372215
Balduino Tschiedel
- Not yet recruiting
Instituto de Pesquisa Clinica
São Paulo, 01223-001
Christiani Poço
- Not yet recruiting
IBTED - Tecnologia e Educação em Diabetes
São Paulo, 04038-032
551197116-9844
Monica Gabbay
Italy7 sites, 7 recruiting
- Not yet recruiting
Ospedale Pediatrico Salesi
Ancona, 60123
390715962011
Valentino Cherubini
- Not yet recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
3384034476
Lorenzo Lenzi
- Not yet recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
+3901056361
Mohamad Maghnie
- Not yet recruiting
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125
Giuseppina Salzano
- Not yet recruiting
Ospedale San Raffaele
Milan, 20132
0226436018
riccardo bonfanti
- Not yet recruiting
University of Naples Federico II
Naples, 80131
Enza Mozzillo
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
0458127662
Claudio Maffeis
Mexico5 sites, 5 recruiting
- Not yet recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440
52 1 833 126 00 55
Rafael Violante Ortiz
- Not yet recruiting
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, 44260
523312044280
Emilia Pelayo Orozco
- Not yet recruiting
UBAM Unidad Biomedica Avanzada Monterrey
Monterrey, 64460
8113578896
Raymundo García Reza
- Not yet recruiting
Clínica García Flores SC
Monterrey, 64610
528113578379
Pedro García Hernández
- Not yet recruiting
Centro de investigación y control metabólico
Monterrey, 66465
8183488973
Samantha Garza Fuentes
South Korea5 sites, 5 recruiting
- Not yet recruiting
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, 14584
Yong Hee Hong
- Not yet recruiting
Kyungpook National University Chilgok Hospital
Deagu, 41404
KYUNGMI JANG
- Not yet recruiting
Chungnam national university hospital
Junggu, 35015
Han Hyuk Lim
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Jaehyun Kim
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Yun Jeong Lee
Belgium3 sites, 3 recruiting
- Not yet recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
3227647052
Philippe Lysy
- Not yet recruiting
UZ Gent
Ghent, 9000
+3293320373
Saskia van der Straaten
- Not yet recruiting
UZ Leuven
Leuven, 3000
+3216343811
Kristina Casteels
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Eduard Mogas Vinals
- Not yet recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
Isabel Leiva
- Not yet recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Constanza Navarro Moreno
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
Sanjay Gupta
- Not yet recruiting
Alder Hey Children's Hospital
Liverpool, L14 5AB
0151 228 4811
Princy Paul
- Not yet recruiting
Royal London Hospital
London, E1 1BB
07906985674
Evelien Gevers
Taiwan2 sites, 2 recruiting
- Not yet recruiting
China Medical University Hospital
Taichung, 404332
Chung-Hsing Wang
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Fu-Sung Lo
About this study
Official title: A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Orforglipron, Dulaglutide
- Keywords
- Pediatric trial, GLP-1 receptor agonist, Oral GLP-1, Small molecule GLP-1, Youth-onset type 2 diabetes, Glycemic control, Continuous glucose monitoring, Non-inferior, Active-controlled
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
DulaglutideDrug
Also called LY2189265
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron | Experimental | Participants will receive orforglipron orally Receives: Drug: Orforglipron |
| Dulaglutide | Active comparator | Participants will receive dulaglutide subcutaneously (SC) Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 40
Secondary outcomes (13)
Change from Baseline in HbA1c
Measured: Baseline, Week 52
Percentage of Participants with HbA1c ≤6.5%
Measured: Week 40
Percent Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 40
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL
Measured: Baseline, during 2 weeks prior to Week 40
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 40
Change from Baseline in Blood Pressure
Measured: Baseline, Week 40
Percent Change from Baseline in Total Cholesterol
Measured: Baseline, Week 40
Change from Baseline in Waist Circumference
Measured: Baseline, Week 40
Change from Baseline in Tanner Staging
Measured: Baseline, Week 52
Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)
Measured: Baseline, Week 40
Change from Baseline in the EQ-5D-Y-5L
Measured: Baseline, Week 40
Number of Participants by Acceptability Response Category
Measured: Baseline, Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
Measured: Predose through Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start8 Jul 2026
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668336
- Sponsor's protocol ID
- 18654
- Other IDs
- J2A-MC-GZGY, 2025-524811-35-00, 2025
- Acronym
- ACHIEVE-PEDS
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.