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Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

2026年10月1日 更新者：Amgen

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

950

阶段

  • 第三阶段

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

  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8L 5G4
        • 招聘中
        • Hamilton Medical Research Group
  • 日本
    • Ehime
      • Matsuyama、Ehime、日本、790-0034
        • 招聘中
        • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
    • Fukuoka
      • Kitakyusyu-shi、Fukuoka、日本、807-0072
        • 招聘中
        • Morizono Medical Clinic
    • Hiroshima
      • Aki-gun、Hiroshima、日本、735-8585
        • 招聘中
        • Mazda Hospital of Mazda Motor Corporation
    • Ibaraki
      • Mito、Ibaraki、日本、310-0826
        • 招聘中
        • Nakamoto Medical Clinic
      • Naka、Ibaraki、日本、311-0113
        • 招聘中
        • Nakakinen Clinic
      • Tsuchiura-shi、Ibaraki、日本、300-0835
        • 招聘中
        • Ohishi Naika Clinic
    • Kumamoto
      • Kumamoto、Kumamoto、日本、860-0863
        • 招聘中
        • Morinaga Ueno Clinic
    • Osaka
      • Kashiwara-shi、Osaka、日本、582-0005
        • 招聘中
        • Shiraiwa Medical Clinic
    • Shizuoka
      • Shizuoka、Shizuoka、日本、424-0855
        • 招聘中
        • Suruga Clinic
    • Tokyo
      • Meguro-ku、Tokyo、日本、153-0053
        • 招聘中
        • Yutenji Medical Clinic
      • Mitaka-shi、Tokyo、日本、181-0013
        • 招聘中
        • Medical Corporation Ouitsukai Kanno Naika
  • 波多黎各
      • San Juan、波多黎各、00909
        • 招聘中
        • Latin Clinical Trial Center
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85296
        • 招聘中
        • Gilbert Center for Family Medicine
    • California
      • Canoga Park、California、美国、91304
        • 招聘中
        • San Fernando Valley Health Institute
      • Cerritos、California、美国、90703
        • 招聘中
        • Core Healthcare Group
      • La Mesa、California、美国、91942
        • 招聘中
        • Velocity Clinical Research Chula Vista
      • Modesto、California、美国、95355
        • 招聘中
        • Paradigm Clinical Research
      • Pomona、California、美国、91767
        • 招聘中
        • Empire Clinical Research
    • Florida
      • Miami、Florida、美国、33135
        • 招聘中
        • Optimus U Corporation
      • Miami、Florida、美国、33015
        • 招聘中
        • San Marcus Research Clinic Inc
      • Miami Lakes、Florida、美国、33016
        • 招聘中
        • Indago Research and Health Center
      • Orlando、Florida、美国、32825
        • 招聘中
        • Florida Institute for Clinical Research
      • Weston、Florida、美国、33331
        • 招聘中
        • Encore Medical Research of Weston LLC
      • Winter Park、Florida、美国、32789
        • 招聘中
        • Conquest Research - Winter Park
    • Illinois
      • Skokie、Illinois、美国、60077
        • 招聘中
        • Endeavor Health
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • 招聘中
        • Iowa Diabetes Research
    • Kansas
      • Lenexa、Kansas、美国、66219
        • 招聘中
        • JCCT- Juno Northwest Houston
      • Newton、Kansas、美国、67114
        • 招聘中
        • Alliance for Multispecialty Research Newton
      • Wichita、Kansas、美国、67226
        • 招聘中
        • Alliance for Multispecialty Research LLC
    • Louisiana
      • Monroe、Louisiana、美国、71201
        • 招聘中
        • Ima Clinical Research- Monroe
    • Maryland
      • Annapolis、Maryland、美国、21401
        • 招聘中
        • Annapolis Internal Medicine, LLC
    • Missouri
      • Kansas City、Missouri、美国、64114
        • 招聘中
        • Alliance for Multispecialty Research - Kansas City
    • Nevada
      • Las Vegas、Nevada、美国、89148
        • 招聘中
        • Palm Research Center Inc
    • New Jersey
      • Trenton、New Jersey、美国、08611
        • 招聘中
        • Premier Research
    • North Carolina
      • Morehead City、North Carolina、美国、28557
        • 招聘中
        • West Clinical Research
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • 招聘中
        • Velocity Clinical Research - Cincinnati
      • Cincinnati、Ohio、美国、45246
        • 招聘中
        • Velocity Clinical Research - Springdale
    • Rhode Island
      • East Greenwich、Rhode Island、美国、02818
        • 招聘中
        • Velocity Clinical Research - Providence
    • Texas
      • Austin、Texas、美国、78704
        • 招聘中
        • Elligo Clinical Research Center
      • Bellaire、Texas、美国、77401
        • 招聘中
        • Johnson County Clinical Trials Juno Bellaire
      • Corpus Christi、Texas、美国、78414
        • 招聘中
        • Osvaldo A Brusco MD PA
      • Denison、Texas、美国、75020
        • 招聘中
        • Soma Clinical Trials, LLC
    • Virginia
      • Burke、Virginia、美国、22015
        • 招聘中
        • Manassas Clinical Research Center Inc
  • 英国
      • Birmingham、英国、B21 9RY
        • 招聘中
        • FutureMeds Birmingham

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 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.

  • Participants completing Study 20210184 must meet the following criteria:

    • Completed the Week 72 visit in Study 20210184.
    • Did not permanently discontinue the investigational product in the parent trial (20210184).
    • Randomized within 7 days of week 72 visit in the parent trial.

  • Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.

Exclusion Criteria:

  • Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.

  • Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m^2).

  • Participant has known sensitivity to any of the products or components to be administered during dosing.

  • History of ischemic optic neuropathy.

  • Any malignancy diagnosed during the parent trial, except for the following treated with curative intent:

    • Nonmelanoma skin cancers
    • Breast ductal carcinoma in situ
    • Cervical carcinoma in situ
    • Prostate cancer in situ

  • Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative[s]) history of medullary thyroid carcinoma (MTC).

  • Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.

  • Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization.

  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.

  • History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.

  • Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.

  • Major surgical procedures planned during the trial.

  • Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.

  • Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

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：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Maridebart Cafraglutide Low Dose Q4W

Participants who received low dose of maridebart cafraglutide in the parent trial (20210184 [NCT06858878]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W).
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
实验性的：Maridebart Cafraglutide Medium Dose Q4W

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
实验性的：Maridebart Cafraglutide Medium dose Q8W

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W).
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
安慰剂比较：Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
药品：Placebo

Administered subcutaneously.
实验性的：Maridebart Cafraglutide High Dose Q4W

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
实验性的：Maridebart Cafraglutide High Dose Q8W

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
安慰剂比较：Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
药品：Placebo

Administered subcutaneously.
实验性的：Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)

Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
药品：Maridebart Cafraglutide

Administered subcutaneously.

其他名称：
  • AMG 133
  • 海地
实验性的：Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)

Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
药品：Maridebart Cafraglutide

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
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Baseline of current trial up to 60 weeks
Baseline of current trial up to 60 weeks
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
大体时间：Baseline of parent trial (20210184) to Week 48 of current trial
Baseline of parent trial (20210184) to Week 48 of current trial

次要结果测量

结果测量
大体时间
Change from Baseline of the Parent Trial in Waist Circumference
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percent Change from Baseline in Body Weight
大体时间：Baseline of current trial to Week 48
Baseline of current trial to Week 48
Percentage of Participants with No Body Weight Gain of >3% From Baseline
大体时间：Week 48 of current trial
Week 48 of current trial
Percentage of Participants with No Body Weight Gain of >5% From Baseline
大体时间：Week 48 of current trial
Week 48 of current trial
Percentage of Body Weight Reduction Maintained from the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in Hemoglobin A1c
大体时间：Baseline of parent trial to Week 48 of current trial
Baseline of parent trial to Week 48 of current trial
Change from Baseline in HbA1c
大体时间：Week 48 of current trial
Week 48 of current trial

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

Amgen

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。

有用的网址

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7月29日

初级完成 (估计的)

2027年12月26日

研究完成 (估计的)

2028年3月19日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29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10月5日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年9月1日

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

  • 20210182
  • 2025-524788-19-00 (克蒂斯)
  • U1111-1332-0531 (其他标识符：WHO/UTN Number)
  • 2025 (美国 NIH 拨款/合同)

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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