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NCT07668336·Phase 3·INTERVENTIONAL

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

DulaglutideType 2 diabetesNot yet recruiting

Status

Not yet recruiting

Phase

Phase 3

Enrollment

170

Locations

71

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Orforglipron

Administered orally

DRUG

Dulaglutide

Administered SC

Timeline

From registration to results.

  1. First posted

    Jun 25, 2026

  2. Study start

    Sep 2026

  3. Primary completion

    Mar 2030

  4. Study completion

    Mar 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline, Week 40

Secondary outcomes

Change from Baseline in HbA1c

Time frame · Baseline, Week 52

Percentage of Participants with HbA1c ≤6.5%

Time frame · Week 40

Percent Change from Baseline in Body Mass Index (BMI)

Time frame · 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

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 40

Change from Baseline in Blood Pressure

Time frame · Baseline, Week 40

Percent Change from Baseline in Total Cholesterol

Time frame · Baseline, Week 40

Change from Baseline in Waist Circumference

Time frame · Baseline, Week 40

Change from Baseline in Tanner Staging

Time frame · Baseline, Week 52

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

Time frame · Baseline, Week 40

Eligibility

Who can take part.

Minimum age
10 Years
Maximum age
17 Years
Sex
ALL
Healthy volunteers
No

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 locations

71 registered sites.

Belgium · Brazil · India · Italy · Japan · Mexico · South Korea · Spain · Taiwan · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

Sacramento, California, United States

Rady Children's Hospital

San Diego, California, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

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

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Medical Research Partners

Ammon, Idaho, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Advantage Clinical Trials

The Bronx, New York, United States

Central States Research

Tulsa, Oklahoma, United States

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States

Gadolin Research

Beaumont, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Proactive Clinical Research LLC

Edinburg, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Victoria Clinical Research Group

Victoria, Texas, United States

Cliniques universitaires Saint-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Instituto de Pesquisa clinica de Campinas

Campinas, Brazil

Centro de Pesquisa Sao Lucas

Campinas, Brazil

Cendi - Endocrinologia e Diabetes

Goiânia, Brazil

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Brazil

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →