一项比较 Orforglipron (LY3502970) 片剂和胶囊在肥胖或超重健康参与者中的研究
一项多剂量研究，旨在调查 Orforglipron (LY3502970) 胶囊和 Orforglipron 片剂在其他方面健康的肥胖或超重参与者中的生物等效性。
这项研究的主要目的是了解健康超重和肥胖受试者服用胶囊剂与片剂相比，有多少 Orforglipron（研究药物）进入血液，以及身体需要多长时间才能将其排出体外。 还将评估 Orforglipron 作为胶囊和片剂给药时的安全性和耐受性（副作用）。
该研究将分两部分进行，A 部分和 B 部分分别持续约 25 周和 22 周，包括筛选期。
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Anaheim、California、美国、92801
- Anaheim Clinical Trials, LLC
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Los Alamitos、California、美国、90720
- Collaborative Neuroscience Research, LLC
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Florida
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Daytona Beach、Florida、美国、32117
- Fortrea Clinical Research Unit
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Kansas
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Overland Park、Kansas、美国、66212
- Altasciences Company Inc.
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Missouri
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Springfield、Missouri、美国、65802
- QPS
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Texas
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Dallas、Texas、美国、75247
- Fortrea Clinical Research Unit
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Wisconsin
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Madison、Wisconsin、美国、53704
- Fortrea Clinical Research Unit
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
- 根据病史和体检确定明显健康的参与者。
- 筛查前 1 个月内体重稳定（体重增加或减少小于或等于 5%）且体重指数 (BMI) 在每平方米 27 至 40 公斤 (kg/m²) 范围内。
- 参与者必须可靠，愿意在研究期间随时投入工作，并愿意遵循研究程序。
- 拥有足够的静脉通路以进行血液采样。
排除标准：
- 糖化血红蛋白 (HbA1c) 水平为 6.5% (%) 或更高。
- 在过去 2 年内有重大抑郁症或精神障碍病史或目前患有重度抑郁症或精神障碍。
- 由其他内分泌失调引起的肥胖，例如库欣综合征或普瑞德威利综合征。
- 已知有临床意义的胃排空异常。
- 接受过减肥手术（例如：Lap-Band、胃绕道手术）
- 已知患有 2A 型或 2B 型多发性内分泌肿瘤、甲状腺 C 细胞增生或任何形式的甲状腺癌的自身史或家族史（一级亲属）。
- 筛查时 12 导联心电图 (ECG) 异常。
- 有胰腺炎病史。
- 研究调查员判断其处于严重的自杀风险，并对哥伦比亚自杀严重程度评定量表 [C-SSRS] 的问题 4 或 5 回答“是”。
- 吞咽胶囊或片剂有困难。
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1)
Participants received LY3502970 orally once daily (QD) across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
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口服给药
其他名称：
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实验性的：Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
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口服给药
其他名称：
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实验性的：Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
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口服给药
其他名称：
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实验性的：Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
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口服给药
其他名称：
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实验性的：Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
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口服给药
其他名称：
|
|
实验性的：Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 4)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
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口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 1)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
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口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
|
口服给药
其他名称：
|
|
实验性的：Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
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口服给药
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7
大体时间：Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
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PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC[0-tau] on Day 7.
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Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
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Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7
大体时间：Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
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PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.
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Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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B 部分：PK：Orforglipron 胶囊在测试剂量水平 1 和 5 下的稳态 AUC(0-τ) 以及相应的片剂剂量强度
大体时间：第 1 天至第 9 周（群组 1）、第 15 周（群组 2）
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QD 给药的 τ 为 24 小时
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第 1 天至第 9 周（群组 1）、第 15 周（群组 2）
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B 部分：PK：Orforglipron 胶囊在测试剂量水平 1 和 5 下的稳态 Cmax 以及相应的片剂剂量强度
大体时间：第 1 天至第 9 周（群组 1）、第 15 周（群组 2）
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第 1 天至第 9 周（群组 1）、第 15 周（群组 2）
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合作者和调查者
调查人员
- 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 18617
- J2A-MC-GZPI (其他标识符：Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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