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Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses

2026年11月2日 更新者:Amgen

A Phase 1, Open-label, Randomized, Parallel Group, Multiple Dose Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity

The main objective of this study is to compare the pharmacokinetics of maridebart cafraglutide administered as a single dose using two different subcutaneous (SC) presentations in participants with overweight or obesity after they have received escalating doses of the study drug.

研究概览

地位

尚未招聘

条件

研究类型

介入性

注册 (估计的)

356

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

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

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults 18 to 60 years of age.
  • Body mass index (BMI) between 25 and 35 kilograms per square meter (kg/m^2), inclusive.
  • Stable body weight, with less than 5 kilograms (kg) (11 pounds) of weight change in the past 3 months.
  • No significant changes in diet or eating habits in the past 3 months.
  • Generally healthy. People with certain well-controlled medical conditions, such as sleep apnea, high blood pressure, high cholesterol, or underactive thyroid, may qualify if their treatment has been stable for at least 3 months and is approved by the study doctor.
  • Willing to follow the study's birth control requirements, if applicable, during the study and for the study-defined period after the last dose of study drug.
  • Able and willing to provide informed consent before participating in study procedures.

Exclusion Criteria:

  • History of diabetes or current diabetes, except diabetes during pregnancy, or blood sugar levels that meet the study's definition of diabetes.
  • Certain hormonal conditions that can cause weight gain, such as Cushing's syndrome.
  • History of pancreatitis (inflammation of the pancreas) or certain abnormal pancreatic blood test results.
  • History of cancer within the past 5 years, except certain early-stage cancers or nonmelanoma skin cancers.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
  • Uncontrolled thyroid disease or certain abnormal thyroid blood test results.
  • Significant stomach or intestinal conditions, including delayed stomach emptying, ulcers, or inflammatory bowel disease, or a history of certain digestive system surgeries.
  • Weight-loss surgery within the past 6 months.
  • Significant heart disease, abnormal heart rhythms, or blood pressure or heart rate outside the study's allowed limits.
  • Significant kidney or liver problems, or certain abnormal kidney or liver blood test results.
  • Positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, with certain exceptions for past hepatitis B vaccination or infection.
  • History of certain serious or unstable mental health conditions, self-injury within the past 5 years, or any previous suicide attempt.
  • History of ischemic optic neuropathy, a condition involving damage to the optic nerve caused by reduced blood flow.
  • Allergy or intolerance to maridebart cafraglutide (AMG 133), similar medications, or their ingredients.
  • Use of certain medications, including weight-loss or diabetes medications that act on glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP), within the restricted time periods before the study.
  • Use of certain herbal products, vitamins, or supplements within 30 days before enrollment, unless approved by the study doctor.
  • Recent participation in another investigational drug study or previous participation in a study of maridebart cafraglutide.
  • History of alcohol or drug abuse, recent illegal drug use, or positive alcohol or drug screening results not explained by permitted prescription medications.
  • Pregnant, breastfeeding, or planning to breastfeed during the study or within the study-defined period after the last dose of study drug.
  • Recent blood, plasma, or platelet donation within the study's restricted time periods.
  • Recent strenuous exercise or unwillingness to follow study restrictions on physical activity, alcohol, recreational drugs, diet, or other activities.
  • Difficulty providing blood samples because of poor vein access.
  • Any other medical condition, abnormal test result, or circumstance that the study doctor believes could make participation unsafe or interfere with study procedures.

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: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
实验性的:Maridebart Cafraglutide: SC Presentation 1

Participants will receive maridebart cafraglutide administered subcutaneously (SC) during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 1.

Administered subcutaneously.

其他名称:
  • AMG 133
  • 海地
实验性的:Maridebart Cafraglutide: SC Presentation 2

Participants will receive maridebart cafraglutide administered SC during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 2.

Administered subcutaneously.

其他名称:
  • AMG 133
  • 海地

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 from Time 0 to 28 days post dose (AUC 0-28) of Maridebart Cafraglutide
大体时间:Up to 113 days
Up to 113 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
大体时间:Up to 113 days
Up to 113 days

次要结果测量

结果测量
大体时间
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间:TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
大体时间:Baseline (Day 1) up to end of trial (approximately 28 weeks)
Baseline (Day 1) up to end of trial (approximately 28 weeks)

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

调查人员

  • 研究主任:MD、Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (估计的)

2026年11月9日

初级完成 (估计的)

2027年7月26日

研究完成 (估计的)

2027年7月26日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

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.

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