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Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-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

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

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)

3200

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 5G8
        • 招聘中
        • Wharton Medical Clinic
      • Thunder Bay、Ontario、加拿大、P7B 6V4
        • 招聘中
        • Curans Heart Center
    • Quebec
      • Chicoutimi、Quebec、加拿大、G7H 7K9
        • 招聘中
        • Ecogene-21
  • 日本
    • Kanagawa
      • Yokohama、Kanagawa、日本、231-0023
        • 招聘中
        • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
    • Tokyo
      • Chiyoda-ku、Tokyo、日本、101-0041
        • 招聘中
        • Doujin Memorial Foundation, Meiwa Hospital
      • Chuo-ku、Tokyo、日本、104-0031
        • 招聘中
        • Tokyo Asbo Clinic
      • Hachioji-shi、Tokyo、日本、192-0046
        • 招聘中
        • Medical Corp Seikoukai New Medical Research System Clinic
      • Minato-ku、Tokyo、日本、108-0075
        • 招聘中
        • Medical Corporation AOT Shinagawa Strings Clinic
      • Shinjuku-ku、Tokyo、日本、160-0004
        • 招聘中
        • Clinical Research Hospital Tokyo
      • Suginami-ku、Tokyo、日本、166-0003
        • 招聘中
        • Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
  • 波多黎各
      • Ponce、波多黎各、00716
        • 招聘中
        • Ponce Medical School Foundation Inc
      • Ponce、波多黎各、00717
        • 招聘中
        • Puerto Rico Medical Research Inc.
      • San Juan、波多黎各、00909
        • 招聘中
        • Latin Clinical Trial Center
  • 澳大利亚
    • New South Wales
      • Botany、New South Wales、澳大利亚、2019
        • 招聘中
        • Emeritus Research Sydney
      • Charlestown、New South Wales、澳大利亚、2290
        • 招聘中
        • Novatrials
      • Miranda、New South Wales、澳大利亚、2228
        • 招聘中
        • Canopy Clinical Sutherland
      • Miranda、New South Wales、澳大利亚、2228
        • 招聘中
        • Canopy Clinical Wollongong
    • Queensland
      • Meadowbrook、Queensland、澳大利亚、4131
        • 招聘中
        • Logan Hospital
    • SAU
      • Adelaide、SAU、澳大利亚、5000
        • 招聘中
        • Fusion Clinical Research
    • Victoria
      • Camberwell、Victoria、澳大利亚、3124
        • 招聘中
        • Emeritus Research Camberwell
      • North Altona、Victoria、澳大利亚、3025
        • 招聘中
        • Canopy Clinical Altona North
  • 美国
    • Alabama
      • Anniston、Alabama、美国、36207
        • 招聘中
        • Pinnacle Research Group LLC
      • Daphne、Alabama、美国、36526
        • 招聘中
        • Alliance For Multispecialty Research - Daphne
      • Mobile、Alabama、美国、36608
        • 招聘中
        • Alliance for Multispecialty Research Mobile
    • California
      • Fountain Valley、California、美国、92708
        • 招聘中
        • Ark Clinical Research- Tustin
      • Long Beach、California、美国、90806
        • 招聘中
        • Long Beach Clinical Trials Services Inc
      • Long Beach、California、美国、90815
        • 招聘中
        • Ark Clinical Research- Long Beach
      • Montclair、California、美国、91763
        • 招聘中
        • Catalina Research Institute
      • Riverside、California、美国、92503
        • 招聘中
        • Artemis Institute for Clinical Research
      • San Diego、California、美国、92103
        • 招聘中
        • Artemis Institute for Clinical Research
      • San Diego、California、美国、92120
        • 招聘中
        • Apex Clinical Research
      • Santa Ana、California、美国、92701
        • 招聘中
        • Southern California Clinical Research
      • Walnut Creek、California、美国、94598
        • 招聘中
        • Diablo Clinical Research
    • Connecticut
      • Waterbury、Connecticut、美国、06708
        • 招聘中
        • Chase Medical Research LLC
    • Florida
      • Jacksonville、Florida、美国、32216
        • 招聘中
        • Jacksonville Center for Clinical Research
      • Jacksonville、Florida、美国、32256
        • 招聘中
        • Clinical Neuroscience Solutions - Jacksonville
      • Lauderhill、Florida、美国、33351
        • 招聘中
        • South Florida Wellness and Clinical Research Institute
      • Miami、Florida、美国、33173
        • 招聘中
        • Research Institute of South Florida
      • Miami、Florida、美国、33135
        • 招聘中
        • Optimus U Corporation
      • Miami Lakes、Florida、美国、33016
        • 招聘中
        • Indago Research and Health Center
      • Ocala、Florida、美国、34470
        • 招聘中
        • Renstar Medical Research
      • Orlando、Florida、美国、32801
        • 招聘中
        • Clinical Neuroscience Solutions - Orlando
      • Orlando、Florida、美国、32825
        • 招聘中
        • Florida Institute for Clinical Research
      • Orlando、Florida、美国、32807
        • 招聘中
        • Combined Research Orlando Phase I IV
      • Weston、Florida、美国、33331
        • 招聘中
        • Encore Medical Research of Weston LLC
    • Georgia
      • Gainesville、Georgia、美国、30501
        • 招聘中
        • Center for Advanced Research and Education
      • Union City、Georgia、美国、30291
        • 招聘中
        • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • 招聘中
        • East-West Medical Research
    • Idaho
      • Meridian、Idaho、美国、83646
        • 招聘中
        • Solaris Clinical Research
    • Illinois
      • Chicago、Illinois、美国、60640
        • 招聘中
        • Flourish Research - Great Lakes Clinical Trials
      • Skokie、Illinois、美国、60077
        • 招聘中
        • Evanston Premier Healthcare Research LLC
      • Skokie、Illinois、美国、60077
        • 招聘中
        • Endeavor Health
    • 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
    • Kentucky
      • Louisville、Kentucky、美国、40213
        • 招聘中
        • Louisville Metabolic and Atherosclerosis Research Center
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 招聘中
        • Velocity Clinical Research - Baton Rouge
      • Marrero、Louisiana、美国、70072
        • 招聘中
        • Tandem Clinical Research - Marrero
    • Michigan
      • Southfield、Michigan、美国、48034
        • 招聘中
        • Headlands Research - Detroit
    • Mississippi
      • Fayette、Mississippi、美国、39069
        • 招聘中
        • Prime Health and Wellness Sky Clinical Research Network Group
    • Missouri
      • Kansas City、Missouri、美国、64114
        • 招聘中
        • Alliance for Multispecialty Research - Kansas City
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • 招聘中
        • Vector Clinical Trials
      • Las Vegas、Nevada、美国、89148
        • 招聘中
        • Palm Research Center Inc
    • New York
      • Binghamton、New York、美国、13905
        • 招聘中
        • Velocity Clinical Research- Binghamton
      • Rochester、New York、美国、14609
        • 招聘中
        • Rochester Clinical Research
    • North Carolina
      • Hickory、North Carolina、美国、28602
        • 招聘中
        • Accellacare of Hickory
      • Shelby、North Carolina、美国、28150
        • 招聘中
        • Carolina Research Center Inc
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • 招聘中
        • Velocity Clinical Research - Cincinnati
      • Cincinnati、Ohio、美国、45212
        • 招聘中
        • Clinical Trial Investigator Clinical Research Center
    • Oklahoma
      • Norman、Oklahoma、美国、73069
        • 招聘中
        • Alliance for Multispecialty Research - Norman
    • Pennsylvania
      • Newport、Pennsylvania、美国、17074
        • 招聘中
        • Capital Area Research LLC
    • Rhode Island
      • East Greenwich、Rhode Island、美国、02818
        • 招聘中
        • Velocity Clinical Research - Providence
    • South Carolina
      • Greenville、South Carolina、美国、29607
        • 招聘中
        • Tribe Clinical Research LLC Dba Mountain View Clinical Research
    • Tennessee
      • Knoxville、Tennessee、美国、37909
        • 招聘中
        • New Phase Research and Development
      • Knoxville、Tennessee、美国、37938
        • 招聘中
        • Accellacare US Inc., d/b/a Accellacare of Knoxville
    • 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
      • Dallas、Texas、美国、75251
        • 招聘中
        • Cedar Health Research, LLC
      • Dallas、Texas、美国、75235
        • 招聘中
        • Cedar Health Research, LLC
      • DeSoto、Texas、美国、75115
        • 招聘中
        • Epic Medical Research - Red Oak
      • El Paso、Texas、美国、79905
        • 招聘中
        • Great Lakes Research Institute El Paso Research
      • Houston、Texas、美国、77043
        • 招聘中
        • Biopharma Informatic, LLC
      • Mesquite、Texas、美国、75149
        • 招聘中
        • Southern Endocrinology Associates PA
      • Pharr、Texas、美国、78557
        • 招聘中
        • Great Lakes Research Institute - McAllen Research
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Clinical Trials of Texas
      • Sugar Land、Texas、美国、77479
        • 招聘中
        • Sugar Lakes Family Practice
    • Utah
      • Bountiful、Utah、美国、84010
        • 招聘中
        • Pantheon Clinical Research
      • Layton、Utah、美国、84041
        • 招聘中
        • Alliance for Multispecialty Research Layton Research Center
      • St. George、Utah、美国、84790
        • 招聘中
        • Chrysalis Clinical Research, LLC
    • Virginia
      • Arlington、Virginia、美国、22206
        • 招聘中
        • Washington Center for Weight Management and Research, Inc
      • Newport News、Virginia、美国、23606
        • 招聘中
        • Health Research of Hampton Roads
      • Winchester、Virginia、美国、22601
        • 招聘中
        • Selma Medical Associates
    • Wisconsin
      • Wauwatosa、Wisconsin、美国、53226
        • 招聘中
        • Allegiance Research Specialists

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) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Completed the parent trial (2010181)
  • Completed week 72 visit in parent trial
  • Did not permanently discontinue trial intervention in parent trial
  • Randomized within 7 Days of week 72 visit in the parent trial
  • Participants must use protocol-specified contraception during treatment, and for an additional 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 ≤ 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 parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
  • Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative[s]) history of medullary thyroid cancer.
  • Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
  • Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from 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, or 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 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
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
实验性的：Maridebart Cafraglutide Low Dose Q4W

Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 [NCT06858839]) 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 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 8weeks (Q8W).
药品：Maridebart cafraglutide

Administered subcutaneously

其他名称：
  • AMG 133
  • 海地
实验性的：Maridebart Cafraglutide High Dose Q12W

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 once in 12 weeks (Q12W).
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
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
大体时间：Baseline of parent trial (20210181) to Week 48 of current trial
Baseline of parent trial (20210181) to Week 48 of current trial
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

次要结果测量

结果测量
大体时间
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 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

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23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

  • 20250197

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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