A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
ACHIEVE-PEDS
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
3 other identifiers
interventional
170
11 countries
71
Brief 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. Participation in the study will last about 61 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Sep 2026
Longer than P75 for phase_3 diabetes-mellitus-type-2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
Study Completion
Last participant's last visit for all outcomes
March 1, 2030
July 20, 2026
July 1, 2026
3.5 years
June 22, 2026
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 40
Secondary Outcomes (13)
Change from Baseline in HbA1c
Baseline, Week 52
Percentage of Participants with HbA1c ≤6.5%
Week 40
Percent Change from Baseline in Body Mass Index (BMI)
Baseline, Week 40
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL
Baseline, during 2 weeks prior to Week 40
Percent Change from Baseline in Body Weight
Baseline, Week 40
- +8 more secondary outcomes
Study Arms (2)
Orforglipron
EXPERIMENTALParticipants will receive orforglipron orally
Dulaglutide
ACTIVE COMPARATORParticipants will receive dulaglutide subcutaneously (SC)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, 95821, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)
Atlanta, Georgia, 30329, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Advantage Clinical Trials
The Bronx, New York, 10467, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Proactive Clinical Research LLC
Edinburg, Texas, 78539, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Victoria Clinical Research Group
Victoria, Texas, 77901, United States
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080, Brazil
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035, Brazil
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
IBTED - Tecnologia e Educação em Diabetes
São Paulo, 04038-032, Brazil
Avron Hospitals
Ahmedabad, 380013, India
Gujarat Endocrin Pvt Ltd
Ahmedabad, 380052, India
Jawaharlal Nehru Medical College
Aligarh, 202002, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Endolife Speciality Hospitals
Guntur, 522001, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, 400012, India
Harmony Health Hub
Nashik, 422002, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Ospedale Pediatrico Salesi
Ancona, 60123, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139, Italy
IRCCS Istituto Giannina Gaslini
Genova, 16147, Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125, Italy
Ospedale San Raffaele
Milan, 20132, Italy
University of Naples Federico II
Naples, 80131, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
Nihon University Hospital
Chiyoda-ku, 101-8309, Japan
Fukuoka Children's Hospital
Fukuoka, 813-0017, Japan
Saitama Medical University Hospital
Iruma, 350-0495, Japan
Shiga General Hospital
Moriyama, 524-8524, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Saitama City Hospital
Saitama, 336-8522, Japan
Sendai City Hospital - Asutonagamachi
Sendai, 982-8502, Japan
Shizuoka Children's Hospital
Shizuoka, 420-8660, Japan
Urakami Pediatric Endocrinology and Diabetes Clinic
Tokyo, 101-0062, Japan
Juntendo University Urayasu Hospital
Urayasu, 279-0021, Japan
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
UBAM Unidad Biomedica Avanzada Monterrey
Monterrey, 64460, Mexico
Clínica García Flores SC
Monterrey, 64610, Mexico
Centro de investigación y control metabólico
Monterrey, 66465, Mexico
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
Kyungpook National University Chilgok Hospital
Deagu, 41404, South Korea
Chungnam national university hospital
Junggu, 35015, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
China Medical University Hospital
Taichung, 404332, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Alder Hey Children's Hospital
Liverpool, L14 5AB, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
June 25, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.