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.
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
- Apex Clinical Research
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Florida
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Miami, Florida, 미국, 33173
- 모병
- Research Institute of South Florida
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Miami, Florida, 미국, 33125
- 모병
- Southern Clinical Research
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Orlando, Florida, 미국, 32825
- 모병
- Florida Institute for Clinical Research
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Orlando, Florida, 미국, 32801
- 모병
- Clinical Neuroscience Solutions LLC
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The Villages, Florida, 미국, 32162
- 모병
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, 미국, 30024
- 모병
- Nsc Research
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Woodstock, Georgia, 미국, 30189
- 모병
- North Georgia Clinical Research
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Idaho
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Meridian, Idaho, 미국, 83646
- 모병
- Solaris Clinical Research
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Illinois
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Oak Brook, Illinois, 미국, 60523
- 모병
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie, Maryland, 미국, 20715
- 모병
- Flourish Research
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New York
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Rochester, New York, 미국, 14609
- 모병
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, 미국, 28557
- 모병
- Centricity Research
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Ohio
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Columbus, Ohio, 미국, 43213
- 모병
- Centricity Research Dublin
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Oklahoma
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Chickasha, Oklahoma, 미국, 73018
- 모병
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville, South Carolina, 미국, 29607
- 모병
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas, Texas, 미국, 75251
- 모병
- Cedar Health Research, LLC
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Dallas, Texas, 미국, 75235
- 모병
- Cedar Health Research- Texas Native Health
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DeSoto, Texas, 미국, 75115
- 모병
- Epic Medical Research - Red Oak
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Denison, Texas, 미국, 75020
- 모병
- Soma Clinical Trials, LLC
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Houston, Texas, 미국, 77043
- 모병
- Biopharma Informatic, LLC
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Houston, Texas, 미국, 77089
- 모병
- Research Physicians Network LLC
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McKinney, Texas, 미국, 75071
- 모병
- Texas Institute of Cardiology
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North Richland Hills, Texas, 미국, 76180
- 모병
- North Hills Medical Research
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San Juan, 푸에르토 리코, 00909
- 모병
- Latin Clinical Trial Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
다른 이름들:
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
기간: 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
기간: Weeks 12, 16, and 20
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Weeks 12, 16, and 20
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2차 결과 측정
결과 측정 |
기간 |
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24주에 체중의 기준선 대비 백분율 변화
기간: 기준선 및 24주차
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기준선 및 24주차
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Number of Participants Who Experience Device-related Adverse Events
기간: 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)
기간: 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
기간: Week 24
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Week 24
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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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20250207
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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