A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes (ACHIEVE-PEDS)

June 22, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Phone Number: 3227647052
        • Principal Investigator:
          • Philippe Lysy
      • Ghent, Belgium, 9000
        • UZ Gent
        • Contact:
          • Phone Number: +3293320373
        • Principal Investigator:
          • Saskia van der Straaten
      • Leuven, Belgium, 3000
        • UZ Leuven
        • Principal Investigator:
          • Kristina Casteels
        • Contact:
          • Phone Number: +3216343811
  • Brazil
      • Campinas, Brazil, 13060-080
        • Instituto de Pesquisa Clinica de Campinas
        • Principal Investigator:
          • Sylka Rodovalho
        • Contact:
          • Phone Number: 55 19 3267 0023
      • Campinas, Brazil, 13060-803
        • Centro de Pesquisa Sao Lucas
        • Contact:
          • Phone Number: 55 19 3343-8688
        • Principal Investigator:
          • Mila Cunha
      • Goiânia, Brazil, 74230-035
        • Cendi - Endocrinologia e Diabetes
        • Contact:
          • Phone Number: 5562992240229
        • Principal Investigator:
          • Nelson Rassi
      • Passo Fundo, Brazil, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
        • Principal Investigator:
          • Hugo Kurtz Lisboa
        • Contact:
          • Phone Number: 55 54 3581 1831
      • Porto Alegre, Brazil, 91350-250
        • Instituto da Crianca com Diabetes
        • Contact:
          • Phone Number: 55133372215
        • Principal Investigator:
          • Balduino Tschiedel
      • São Paulo, Brazil, 04038-032
        • IBTED - Tecnologia e Educação em Diabetes
        • Contact:
          • Phone Number: 551197116-9844
        • Principal Investigator:
          • Monica Gabbay
      • São Paulo, Brazil, 01223-001
        • Instituto de Pesquisa Clinica
        • Principal Investigator:
          • Christiani Poço
  • India
      • Ahmedabad, India, 380052
        • Gujarat Endocrin Pvt Ltd
        • Principal Investigator:
          • parag Shah
        • Contact:
          • Phone Number: 91-9824042688
      • Ahmedabad, India, 380013
        • Avron Hospitals
        • Principal Investigator:
          • Tiven Marwah
        • Contact:
          • Phone Number: 079 66 200480
      • Aligarh, India, 202002
        • Jawaharlal Nehru Medical College
        • Principal Investigator:
          • Hamid Ashraf
      • Bhubaneswar, India, 751019
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Kishore Behera
        • Contact:
          • Phone Number: 0674-2476789
      • Guntur, India, 522001
        • Endolife Speciality Hospitals
        • Principal Investigator:
          • Kongara Srikanth
        • Contact:
          • Phone Number: 9849945577
      • Mumbai, India, 400012
        • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
        • Principal Investigator:
          • Manjiri Karlekar
      • Nashik, India, 422002
        • Harmony Health Hub
        • Principal Investigator:
          • Tushar Godbole
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Rajesh Khadgawat
        • Contact:
          • Phone Number: 91-11-26593237
  • Italy
      • Ancona, Italy, 60123
        • Ospedale Pediatrico Salesi
        • Contact:
          • Phone Number: 390715962011
        • Principal Investigator:
          • Valentino Cherubini
      • Florence, Italy, 50139
        • Azienda Ospedaliera Universitaria Meyer IRCCS
        • Contact:
          • Phone Number: 3384034476
        • Principal Investigator:
          • Lorenzo Lenzi
      • Genova, Italy, 16147
        • IRCCS Istituto Giannina Gaslini
        • Contact:
          • Phone Number: +3901056361
        • Principal Investigator:
          • Mohamad Maghnie
      • Messina, Italy, 98125
        • Azienda Ospedaliera Universitaria Di Messina G. Martino
        • Principal Investigator:
          • Giuseppina Salzano
      • Milan, Italy, 20132
        • Ospedale San Raffaele
        • Principal Investigator:
          • riccardo bonfanti
        • Contact:
          • Phone Number: 0226436018
      • Naples, Italy, 80131
        • University of Naples Federico II
        • Principal Investigator:
          • Enza Mozzillo
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
        • Contact:
          • Phone Number: 0458127662
        • Principal Investigator:
          • Claudio Maffeis
  • Japan
      • Chiyoda-ku, Japan, 101-8309
        • Nihon University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Junichi Suzuki
      • Fukuoka, Japan, 813-0017
        • Fukuoka Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenichi Miyako
      • Iruma, Japan, 350-0495
        • Saitama Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toru Kikuchi
      • Moriyama, Japan, 524-8524
        • Shiga General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Katsuyuki Matsui
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yohei Ogawa
      • Osaka, Japan, 534-0021
        • Osaka City General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Mori
      • Saitama, Japan, 336-8522
        • Saitama City Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masayuki Akashi
      • Sendai, Japan, 982-8502
        • Sendai City Hospital - Asutonagamachi
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ikuma Fujiwara
      • Shizuoka, Japan, 420-0953
        • Shizuoka Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shinichiro Sano
      • Tokyo, Japan, 101-0062
        • Urakami Pediatric Endocrinology and Diabetes Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tatsuhiko Urakami
      • Urayasu, Japan, 279-0021
        • Juntendo University Urayasu Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Satoh
  • Mexico
      • Ciudad Madero, Mexico, 89440
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
        • Principal Investigator:
          • Rafael Violante Ortiz
        • Contact:
          • Phone Number: 52 1 833 126 00 55
      • Guadalajara, Mexico, 44260
        • Centro de Investigacion Medica de Occidente, S.C.
        • Contact:
          • Phone Number: 523312044280
        • Principal Investigator:
          • Emilia Pelayo Orozco
      • Monterrey, Mexico, 64460
        • UBAM Unidad Biomedica Avanzada Monterrey
        • Contact:
          • Phone Number: 8113578896
        • Principal Investigator:
          • Raymundo García Reza
      • Monterrey, Mexico, 64610
        • Clínica García Flores SC
        • Contact:
          • Phone Number: 528113578379
        • Principal Investigator:
          • Pedro García Hernández
      • Monterrey, Mexico, 66465
        • Centro de investigación y control metabólico
        • Contact:
          • Phone Number: 8183488973
        • Principal Investigator:
          • Samantha Garza Fuentes
  • South Korea
      • Bucheon-si, South Korea, 14584
        • Soon Chun Hyang University Bucheon Hospital
        • Principal Investigator:
          • Yong Hee Hong
      • Deagu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • KYUNGMI JANG
      • Junggu, South Korea, 35015
        • Chungnam National University Hospital
        • Principal Investigator:
          • Han Hyuk Lim
      • Seongnam, South Korea, 13620
        • Seoul national university Bundang hospital
        • Principal Investigator:
          • Jaehyun Kim
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Principal Investigator:
          • Young Ah Lee
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Eduard Mogas Vinals
      • Málaga, Spain, 29011
        • H.R.U Málaga - Hospital General
        • Principal Investigator:
          • Isabel Leiva
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
        • Principal Investigator:
          • Constanza Navarro Moreno
  • Taiwan
      • Taichung, Taiwan, 404332
        • China Medical University Hospital
        • Principal Investigator:
          • Chung-Hsing Wang
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Fu-Sung Lo
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
        • Principal Investigator:
          • Sanjay Gupta
      • Liverpool, United Kingdom, L14 5AB
        • Alder Hey Children's Hospital
        • Contact:
          • Phone Number: 0151 228 4811
        • Principal Investigator:
          • Princy Paul
      • London, United Kingdom, E1 1BB
        • Royal London Hospital
        • Contact:
          • Phone Number: 07906985674
        • Principal Investigator:
          • Evelien Gevers
  • United States
    • California
      • Sacramento, California, United States, 95821
        • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
        • Contact:
          • Phone Number: 916-426-1902
        • Principal Investigator:
          • Gnanagurudasan Prakasam
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
        • Principal Investigator:
          • Carla Demeterco-Berggren
        • Contact:
          • Phone Number: 858-966-8940
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
        • Principal Investigator:
          • David Radin
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
        • Contact:
          • Phone Number: 404-537-1281
        • Principal Investigator:
          • Kimball Johnson
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
        • Contact:
          • Phone Number: 208-522-4600
        • Principal Investigator:
          • Mitchael Steorts
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
        • Principal Investigator:
          • susan brian
        • Contact:
          • Phone Number: 785-354-9591
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • The Bronx, New York, United States, 10467
        • Advantage Clinical Trials
        • Principal Investigator:
          • Giancarlo Guido
        • Contact:
          • Phone Number: 917-962-0234
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research
        • Contact:
          • Phone Number: 918-645-5400
        • Principal Investigator:
          • Sarah Land
    • Pennsylvania
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
        • Principal Investigator:
          • Marcy Goisse
        • Contact:
          • Phone Number: 724-569-8036
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Health One Hundred Oaks
        • Contact:
          • Phone Number: 225-226-5662
        • Principal Investigator:
          • Gitanjali Srivastava
    • Texas
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
        • Contact:
          • Phone Number: 409-331-6040
        • Principal Investigator:
          • John Fowler
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
        • Principal Investigator:
          • Ana Paez
        • Contact:
          • Phone Number: 361-739-7250
      • Edinburg, Texas, United States, 78539
        • Proactive Clinical Research LLC
        • Principal Investigator:
          • Gerardo Orfanos
        • Contact:
          • Phone Number: 956-731-1260
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
      • Victoria, Texas, United States, 77901
        • Victoria Clinical Research Group
        • Contact:
          • Phone Number: 361-210-7869
        • Principal Investigator:
          • John Clinton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Active Comparator: Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in HbA1c
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants with HbA1c ≤6.5%
Time Frame: Week 40
Week 40
Percent Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL
Time Frame: Baseline, during 2 weeks prior to Week 40
Baseline, during 2 weeks prior to Week 40
Change from Baseline in Blood Pressure
Time Frame: Baseline, Week 40
Baseline, Week 40
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Tanner Staging
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in the EQ-5D-Y-5L
Time Frame: Baseline, Week 40
Baseline, Week 40
Number of Participants by Acceptability Response Category
Time Frame: Baseline, Week 52
Baseline, Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
Time Frame: Predose through Week 30
Predose through Week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18654
  • J2A-MC-GZGY (Other Identifier: Eli Lilly and Company)
  • 2025-524811-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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