Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight (MARITIME-PEN)
A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus
The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Amgen Call Center
- 电话号码：866-572-6436
- 邮箱：medinfo@amgen.com
学习地点
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San Juan、波多黎各、00909
- 招聘中
- Latin Clinical Trial Center
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California
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San Diego、California、美国、92120
- 招聘中
- Apex Clinical Research
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Florida
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Miami、Florida、美国、33173
- 招聘中
- Research Institute of South Florida
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Miami、Florida、美国、33125
- 招聘中
- Southern Clinical Research
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Orlando、Florida、美国、32825
- 招聘中
- Florida Institute for Clinical Research
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Orlando、Florida、美国、32801
- 招聘中
- Clinical Neuroscience Solutions LLC
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The Villages、Florida、美国、32162
- 招聘中
- Charter Research - The Villages
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Georgia
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Johns Creek、Georgia、美国、30024
- 招聘中
- Nsc Research
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Woodstock、Georgia、美国、30189
- 招聘中
- North Georgia Clinical Research
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Idaho
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Meridian、Idaho、美国、83646
- 招聘中
- Solaris Clinical Research
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Illinois
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Oak Brook、Illinois、美国、60523
- 招聘中
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie、Maryland、美国、20715
- 招聘中
- Flourish Research
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New York
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Rochester、New York、美国、14609
- 招聘中
- Rochester Clinical Research
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North Carolina
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Morehead City、North Carolina、美国、28557
- 招聘中
- Centricity Research
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Ohio
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Columbus、Ohio、美国、43213
- 招聘中
- Centricity Research Dublin
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Oklahoma
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Chickasha、Oklahoma、美国、73018
- 招聘中
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville、South Carolina、美国、29607
- 招聘中
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas、Texas、美国、75251
- 招聘中
- Cedar Health Research, LLC
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Dallas、Texas、美国、75235
- 招聘中
- Cedar Health Research- Texas Native Health
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DeSoto、Texas、美国、75115
- 招聘中
- Epic Medical Research - Red Oak
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Denison、Texas、美国、75020
- 招聘中
- Soma Clinical Trials, LLC
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Houston、Texas、美国、77043
- 招聘中
- Biopharma Informatic, LLC
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Houston、Texas、美国、77089
- 招聘中
- Research Physicians Network LLC
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McKinney、Texas、美国、75071
- 招聘中
- Texas Institute of Cardiology
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North Richland Hills、Texas、美国、76180
- 招聘中
- North Hills Medical Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m^2), or BMI ≥ 27 to < 30 kg/m^2 with one of the following:
- hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
- dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
- history of obstructive sleep apnea
- history of cardiovascular disease
- history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease [MASLD] or metabolic dysfunction-associated steatohepatitis [MASH])
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At least 1 unsuccessful attempt at weight loss by diet and exercise.
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Contraception for females.
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Willingness to follow trial procedures for the duration of the trial.
Exclusion Criteria:
- Obesity induced by other endocrinologic disorders.
- Change in body weight > 5 kg within last 90 days.
- Previous or planned surgical, endoscopic, or device-based treatment for obesity.
- History of malignancy within the past 5 years.
- Type 1 or Type 2 diabetes mellitus.
- History of chronic pancreatitis or history of acute pancreatitis within last 180 days.
- Family or personal history of medullary thyroid cancer.
- Previous participation in a Maridebart Cafraglutide trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 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：Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
其他名称：
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
大体时间：Weeks 12, 16, and 20
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Weeks 12, 16, and 20
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Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration
大体时间：Weeks 12, 16, and 20
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Weeks 12, 16, and 20
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次要结果测量
结果测量 |
大体时间 |
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第 24 周时体重相对于基线的百分比变化
大体时间：基线和第 24 周
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基线和第 24 周
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Number of Participants Who Experience Device-related Adverse Events
大体时间：Up To 37 weeks
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Up To 37 weeks
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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 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
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TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
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Plasma Concentration of Maridebart Cafraglutide at Week 24
大体时间：Week 24
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Week 24
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合作者和调查者
赞助
调查人员
- 研究主任：MD、Amgen
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 (估计的)
研究完成 (估计的)
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
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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
研究美国 FDA 监管的设备产品
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.