2025-524811-35-00RecruitingPhase 3
J2A-MC-GZGY: 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly & Co.
- Enrollment
- 22
- Locations
- 13
- Primary Endpoint
- Change from Baseline in Hemoglobin A1c (HbA1c)
Study Overview
Brief Summary
To demonstrate that orforglipron is noninferior to dulaglutide in glycemic control using an NIM of 0.4%
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts 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
Arms & Interventions
DULAGLUTIDE
Comparator
Intervention: DULAGLUTIDE (Drug)
ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, Orforglipron, ORFORGLIPRON
Test
Intervention: ORFORGLIPRON (Drug)
ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, Orforglipron, ORFORGLIPRON
Test
Intervention: Orforglipron (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary Outcomes
No secondary outcomes reported
Investigators
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
Study Sites (13)
Loading locations...
Similar Trials
Recruiting
Phase 3
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee ( ATTAIN-OA PAIN )Osteoarthritis2025-522631-34-00Eli Lilly & Co.115
Recruiting
Phase 3
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan FastingDiabetes Mellitus, Type 2Membrane ProteinsProteinsReceptors, PeptideReceptors, Cell SurfaceDiabetes MelletusGlucose Metabolism DisordersMetabolic DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehaviorFastingGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledNCT07613307Eli Lilly and Company130
Recruiting
Phase 3
A study to find out if the study drug elecoglipron helps adults with type 2 diabetes mellitus by comparing it with semaglutide, a medicine already used to treat type 2 diabetes mellitustype 2 diabetes mellitus2025-523933-24-00AstraZeneca AB335
Active, not recruiting
Phase 3
在 2 型糖重参与者中评价 orforglipron 片剂片剂的有效性和安全性研究成人 2 型糖尿病CTR20252895Eli Lilly and Company/
礼来苏州制药有限公司/
Lilly del Caribe, Inc.
Completed
Phase 3
在二甲双胍治疗后血糖控制不佳的 2 型糖尿病受试者中评价 orforglipron 与达格列净相比的作用（ACHIEVE-2）2 型糖尿病CTR20234303Eli Lilly and Company/
礼来苏州制药有限公司/
Lilly del Caribe, Inc.