NCT07668336尚未招募3 期
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
- 尚未招募
- 入组人数
- 170
- 试验地点
- 71
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 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
Orforglipron
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Dulaglutide
Active Comparator
Participants will receive dulaglutide subcutaneously (SC)
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 40
次要结局
- Change from Baseline in HbA1c(Baseline, Week 52)
- Percentage of Participants with HbA1c ≤6.5%(Week 40)
- Percent Change from Baseline in Body Mass Index (BMI)(Baseline, Week 40)
- Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL(Baseline, during 2 weeks prior to Week 40)
- Percent Change from Baseline in Body Weight(Baseline, Week 40)
- Change from Baseline in Blood Pressure(Baseline, Week 40)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 40)
- Change from Baseline in Waist Circumference(Baseline, Week 40)
- Change from Baseline in Tanner Staging(Baseline, Week 52)
- Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)(Baseline, Week 40)
- Change from Baseline in the EQ-5D-Y-5L(Baseline, Week 40)
- Number of Participants by Acceptability Response Category(Baseline, Week 52)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron(Predose through Week 30)
研究者
研究点 (71)
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