此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

2026年6月26日 更新者：Zealand Pharma

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function

This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.

The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.

Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.

Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.

研究类型

介入性

注册 (估计的)

36

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 斯洛伐克
    • Bratislava Region
      • Bratislava、Bratislava Region、斯洛伐克、831 01
        • 招聘中
        • Summit Clinical Research s.r.o.
        • 接触：
    • Malacky
      • Malacky、Malacky、斯洛伐克、901 01
  • 波兰
    • Poland
      • Wroclaw、Poland、波兰、51-162
        • 招聘中
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

All participants:

  1. Sex: male and female participants.

  2. Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.

    Additional Inclusion Criteria for Participants with Normal Hepatic Function

  3. Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..

  4. Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.

    Additional Inclusion Criteria for Participants with Hepatic Impairment

  5. Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
  6. Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
  7. Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.

Exclusion Criteria:

All participants:

  1. Known or suspected hypersensitivity to the IMP or related products.
  2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 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
实验性的：Petrelintide: Normal Hepatic Function
Participants with normal hepatic function will receive a single SC dose of petrelintide.
药品：Petrelintide
Petrelintide will be administered as a single SC injection.
其他名称：
  • ZP8396
实验性的：Petrelintide: Mild HI
Participants with mild HI will receive a single SC dose of petrelintide.
药品：Petrelintide
Petrelintide will be administered as a single SC injection.
其他名称：
  • ZP8396
实验性的：Petrelintide: Moderate HI
Participants with moderate HI will receive a single SC dose of petrelintide.
药品：Petrelintide
Petrelintide will be administered as a single SC injection.
其他名称：
  • ZP8396
实验性的：Petrelintide: Severe HI
Participants with severe HI will receive a single SC dose of petrelintide.
药品：Petrelintide
Petrelintide will be administered as a single SC injection.
其他名称：
  • ZP8396

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)

次要结果测量

结果测量
大体时间
AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Time to Cmax (tmax)
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Clearance (CL/F) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Terminal Elimination Half-life (t1/2) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
大体时间：Day 1 (pre-dose) to Day 50 (Follow-up)
Day 1 (pre-dose) to Day 50 (Follow-up)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
大体时间：Day 1 up to Day 50
Day 1 up to Day 50

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Zealand Pharma

调查人员

  • 首席研究员：Clinical Trial Information Desk、Zealand Pharma A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (估计的)

2027年4月12日

研究完成 (估计的)

2027年4月12日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ZP8396-25077
  • Universal Trial number (其他标识符：U1111-1328-8578)
  • 2025-523641-10-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅