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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name ACHIEVE-PEDS

NCTNCT07668336 (opens ClinicalTrials.gov in a new tab)Other id18654Other idJ2A-MC-GZGYOther id2025-524811-35-00Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
170 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
11 countries

United States, Belgium, Brazil, India, Italy, Japan, Mexico, South Korea, Spain, Taiwan, United Kingdom

Start
8 Jul 2026
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
First posted
25 Jun 2026
Last update posted
19 Oct 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028202920302031
  1. Ph 3

    ACHIEVE-PEDS

    NCT07668336

    8 Jul 2026 to est. Mar 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • DulaglutideDrug

Arms2

  • Experimental

    Orforglipron

    Participants will receive orforglipron orally

  • Active comparator

    Dulaglutide

    Participants will receive dulaglutide subcutaneously (SC)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 40

Secondary outcomes(13)

  1. Change from Baseline in HbA1c

    Time frame · Baseline, Week 52

  2. Percentage of Participants with HbA1c ≤6.5%

    Time frame · Week 40

  3. Percent Change from Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 40

  4. Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL

    Time frame · Baseline, during 2 weeks prior to Week 40

  5. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 40

  6. Change from Baseline in Blood Pressure

    Time frame · Baseline, Week 40

  7. Percent Change from Baseline in Total Cholesterol

    Time frame · Baseline, Week 40

  8. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 40

  9. Change from Baseline in Tanner Staging

    Time frame · Baseline, Week 52

  10. Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)

    Time frame · Baseline, Week 40

  11. Change from Baseline in the EQ-5D-Y-5L

    Time frame · Baseline, Week 40

  12. Number of Participants by Acceptability Response Category

    Time frame · Baseline, Week 52

  13. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron

    Time frame · Predose through Week 30

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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