2025-524811-35-00招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 13
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
To demonstrate that orforglipron is noninferior to dulaglutide in glycemic control using an NIM of 0.4%
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DULAGLUTIDE
Comparator
干预措施: DULAGLUTIDE (Drug)
ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, Orforglipron, ORFORGLIPRON
Test
干预措施: ORFORGLIPRON (Drug)
ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, ORFORGLIPRON, Orforglipron, ORFORGLIPRON
Test
干预措施: Orforglipron (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Hemoglobin A1c (HbA1c)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (13)
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