Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes (MARITIME-T2D-3)
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
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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British Columbia
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Vancouver、British Columbia、加拿大、V5Y 3W2
- 招聘中
- Dr T G Elliott Incorporated - BC Diabetes
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California
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San Diego、California、美国、92120
- 招聘中
- Acclaim Clinical Research
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Florida
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Miami、Florida、美国、33155
- 招聘中
- Bioclinical Research Alliance
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Miami Lakes、Florida、美国、33016
- 招聘中
- Indago Research and Health Center
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Pompano Beach、Florida、美国、33060
- 招聘中
- Clinical Research Center Of Florida
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Winter Park、Florida、美国、32789
- 招聘中
- Conquest Research - Winter Park
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Virginia
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Arlington、Virginia、美国、22205
- 招聘中
- Virginia Nephrology Group
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Washington
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Redmond、Washington、美国、98052
- 招聘中
- Eastside Research Associates Health 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:
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.
Exclusion Criteria:
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Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
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Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
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Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
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One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
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History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
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Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
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Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:
- liposuction and/or abdominoplasty that was performed > 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.
学习计划
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：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 maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
其他名称：
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有源比较器：Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
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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Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
大体时间：Baseline to Week 68
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Baseline to Week 68
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Plasma Concentration of Maridebart Cafraglutide at Week 68
大体时间：Week 68
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Week 68
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Change from Baseline in HbA1c at week 68 [Superiority]
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percent Change from Baseline in Body Weight at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c < 7.0% at Week 68
大体时间：Week 68
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Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
大体时间：Week 68
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Week 68
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
大体时间：Week 68
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Week 68
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Change from Baseline in Fasting Plasma Glucose at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
大体时间：Baseline to Week 68
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Baseline to Week 68
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Up To 81 Weeks
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Up To 81 Weeks
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Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
大体时间：Up To 81 Weeks
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Up To 81 Weeks
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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
其他相关的 MeSH 术语
其他研究编号
- 20230220
- 2025 (美国 NIH 拨款/合同)
- 2025-523772-22-00 (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)？
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
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