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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Amgen Call Center
- 전화번호: 866-572-6436
- 이메일: medinfo@amgen.com
연구 장소
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California
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San Diego, California, 미국, 92120
- 모병
- Acclaim Clinical Research
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Florida
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Miami, Florida, 미국, 33155
- 모병
- Bioclinical Research Alliance
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Miami Lakes, Florida, 미국, 33016
- 모병
- Indago Research and Health Center
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Pompano Beach, Florida, 미국, 33060
- 모병
- Clinical Research Center Of Florida
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Winter Park, Florida, 미국, 32789
- 모병
- Conquest Research - Winter Park
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Virginia
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Arlington, Virginia, 미국, 22205
- 모병
- Virginia Nephrology Group
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Washington
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Redmond, Washington, 미국, 98052
- 모병
- Eastside Research Associates Health Research
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Y 3W2
- 모병
- Dr T G Elliott Incorporated - BC Diabetes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
다른 이름들:
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활성 비교기: Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
기간: Baseline to Week 68
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Baseline to Week 68
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2차 결과 측정
결과 측정 |
기간 |
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Plasma Concentration of Maridebart Cafraglutide at Week 68
기간: Week 68
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Week 68
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Change from Baseline in HbA1c at week 68 [Superiority]
기간: 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
기간: 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
기간: Week 68
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Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
기간: Week 68
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Week 68
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
기간: Week 68
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Week 68
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Change from Baseline in Fasting Plasma Glucose at Week 68
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: Up To 81 Weeks
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Up To 81 Weeks
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20230220
- 2025 (미국 NIH 보조금/계약)
- 2025-523772-22-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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