Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
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).
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
-
-
Alabama
-
Anniston, Alabama, 미국, 36207
- 모병
- Pinnacle Research Group LLC
-
Daphne, Alabama, 미국, 36526
- 모병
- Alliance For Multispecialty Research - Daphne
-
Mobile, Alabama, 미국, 36608
- 모병
- Alliance for Multispecialty Research Mobile
-
-
California
-
Fountain Valley, California, 미국, 92708
- 모병
- Ark Clinical Research- Tustin
-
Long Beach, California, 미국, 90806
- 모병
- Long Beach Clinical Trials Services Inc
-
Long Beach, California, 미국, 90815
- 모병
- Ark Clinical Research- Long Beach
-
Montclair, California, 미국, 91763
- 모병
- Catalina Research Institute
-
Riverside, California, 미국, 92503
- 모병
- Artemis Institute for Clinical Research
-
San Diego, California, 미국, 92103
- 모병
- Artemis Institute for Clinical Research
-
San Diego, California, 미국, 92120
- 모병
- Apex Clinical Research
-
Santa Ana, California, 미국, 92701
- 모병
- Southern California Clinical Research
-
Walnut Creek, California, 미국, 94598
- 모병
- Diablo Clinical Research
-
-
Connecticut
-
Waterbury, Connecticut, 미국, 06708
- 모병
- Chase Medical Research LLC
-
-
Florida
-
Jacksonville, Florida, 미국, 32216
- 모병
- Jacksonville Center for Clinical Research
-
Jacksonville, Florida, 미국, 32256
- 모병
- Clinical Neuroscience Solutions - Jacksonville
-
Lauderhill, Florida, 미국, 33351
- 모병
- South Florida Wellness and Clinical Research Institute
-
Miami, Florida, 미국, 33173
- 모병
- Research Institute of South Florida
-
Miami, Florida, 미국, 33135
- 모병
- Optimus U Corporation
-
Miami Lakes, Florida, 미국, 33016
- 모병
- Indago Research and Health Center
-
Ocala, Florida, 미국, 34470
- 모병
- Renstar Medical Research
-
Orlando, Florida, 미국, 32801
- 모병
- Clinical Neuroscience Solutions - Orlando
-
Orlando, Florida, 미국, 32825
- 모병
- Florida Institute for Clinical Research
-
Orlando, Florida, 미국, 32807
- 모병
- Combined Research Orlando Phase I IV
-
Weston, Florida, 미국, 33331
- 모병
- Encore Medical Research of Weston LLC
-
-
Georgia
-
Gainesville, Georgia, 미국, 30501
- 모병
- Center for Advanced Research and Education
-
Union City, Georgia, 미국, 30291
- 모병
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
-
-
Hawaii
-
Honolulu, Hawaii, 미국, 96814
- 모병
- East-West Medical Research
-
-
Idaho
-
Meridian, Idaho, 미국, 83646
- 모병
- Solaris Clinical Research
-
-
Illinois
-
Chicago, Illinois, 미국, 60640
- 모병
- Flourish Research - Great Lakes Clinical Trials
-
Skokie, Illinois, 미국, 60077
- 모병
- Evanston Premier Healthcare Research LLC
-
Skokie, Illinois, 미국, 60077
- 모병
- Endeavor Health
-
-
Kansas
-
Lenexa, Kansas, 미국, 66219
- 모병
- JCCT- Juno Northwest Houston
-
Newton, Kansas, 미국, 67114
- 모병
- Alliance for Multispecialty Research Newton
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40213
- 모병
- Louisville Metabolic and Atherosclerosis Research Center
-
-
Louisiana
-
Baton Rouge, Louisiana, 미국, 70809
- 모병
- Velocity Clinical Research - Baton Rouge
-
Marrero, Louisiana, 미국, 70072
- 모병
- Tandem Clinical Research - Marrero
-
-
Michigan
-
Southfield, Michigan, 미국, 48034
- 모병
- Headlands Research - Detroit
-
-
Mississippi
-
Fayette, Mississippi, 미국, 39069
- 모병
- Prime Health and Wellness Sky Clinical Research Network Group
-
-
Missouri
-
Kansas City, Missouri, 미국, 64114
- 모병
- Alliance for Multispecialty Research - Kansas City
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89128
- 모병
- Vector Clinical Trials
-
Las Vegas, Nevada, 미국, 89148
- 모병
- Palm Research Center Inc
-
-
New York
-
Binghamton, New York, 미국, 13905
- 모병
- Velocity Clinical Research- Binghamton
-
Rochester, New York, 미국, 14609
- 모병
- Rochester Clinical Research
-
-
North Carolina
-
Hickory, North Carolina, 미국, 28602
- 모병
- Accellacare of Hickory
-
Shelby, North Carolina, 미국, 28150
- 모병
- Carolina Research Center Inc
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45219
- 모병
- Velocity Clinical Research - Cincinnati
-
Cincinnati, Ohio, 미국, 45212
- 모병
- Clinical Trial Investigator Clinical Research Center
-
-
Oklahoma
-
Norman, Oklahoma, 미국, 73069
- 모병
- Alliance for Multispecialty Research - Norman
-
-
Pennsylvania
-
Newport, Pennsylvania, 미국, 17074
- 모병
- Capital Area Research LLC
-
-
Rhode Island
-
East Greenwich, Rhode Island, 미국, 02818
- 모병
- Velocity Clinical Research - Providence
-
-
South Carolina
-
Greenville, South Carolina, 미국, 29607
- 모병
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
-
-
Tennessee
-
Knoxville, Tennessee, 미국, 37909
- 모병
- New Phase Research and Development
-
Knoxville, Tennessee, 미국, 37938
- 모병
- Accellacare US Inc., d/b/a Accellacare of Knoxville
-
-
Texas
-
Austin, Texas, 미국, 78704
- 모병
- Elligo Clinical Research Center
-
Bellaire, Texas, 미국, 77401
- 모병
- Johnson County Clinical Trials Juno Bellaire
-
Dallas, Texas, 미국, 75251
- 모병
- Cedar Health Research, LLC
-
Dallas, Texas, 미국, 75235
- 모병
- Cedar Health Research, LLC
-
DeSoto, Texas, 미국, 75115
- 모병
- Epic Medical Research - Red Oak
-
El Paso, Texas, 미국, 79905
- 모병
- Great Lakes Research Institute El Paso Research
-
Houston, Texas, 미국, 77043
- 모병
- Biopharma Informatic, LLC
-
Mesquite, Texas, 미국, 75149
- 모병
- Southern Endocrinology Associates PA
-
Pharr, Texas, 미국, 78557
- 모병
- Great Lakes Research Institute - McAllen Research
-
San Antonio, Texas, 미국, 78229
- 모병
- Clinical Trials of Texas
-
Sugar Land, Texas, 미국, 77479
- 모병
- Sugar Lakes Family Practice
-
-
Utah
-
Bountiful, Utah, 미국, 84010
- 모병
- Pantheon Clinical Research
-
Layton, Utah, 미국, 84041
- 모병
- Alliance for Multispecialty Research Layton Research Center
-
St. George, Utah, 미국, 84790
- 모병
- Chrysalis Clinical Research, LLC
-
-
Virginia
-
Arlington, Virginia, 미국, 22206
- 모병
- Washington Center for Weight Management and Research, Inc
-
Newport News, Virginia, 미국, 23606
- 모병
- Health Research of Hampton Roads
-
Winchester, Virginia, 미국, 22601
- 모병
- Selma Medical Associates
-
-
Wisconsin
-
Wauwatosa, Wisconsin, 미국, 53226
- 모병
- Allegiance Research Specialists
-
-
-
-
Kanagawa
-
Yokohama, Kanagawa, 일본, 231-0023
- 모병
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
-
-
Tokyo
-
Chiyoda-ku, Tokyo, 일본, 101-0041
- 모병
- Doujin Memorial Foundation, Meiwa Hospital
-
Chuo-ku, Tokyo, 일본, 104-0031
- 모병
- Tokyo Asbo Clinic
-
Hachioji-shi, Tokyo, 일본, 192-0046
- 모병
- Medical Corp Seikoukai New Medical Research System Clinic
-
Minato-ku, Tokyo, 일본, 108-0075
- 모병
- Medical Corporation AOT Shinagawa Strings Clinic
-
Shinjuku-ku, Tokyo, 일본, 160-0004
- 모병
- Clinical Research Hospital Tokyo
-
Suginami-ku, Tokyo, 일본, 166-0003
- 모병
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
-
-
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8L 5G8
- 모병
- Wharton Medical Clinic
-
Thunder Bay, Ontario, 캐나다, P7B 6V4
- 모병
- Curans Heart Center
-
-
Quebec
-
Chicoutimi, Quebec, 캐나다, G7H 7K9
- 모병
- Ecogene-21
-
-
-
-
-
Ponce, 푸에르토 리코, 00716
- 모병
- Ponce Medical School Foundation Inc
-
Ponce, 푸에르토 리코, 00717
- 모병
- Puerto Rico Medical Research Inc.
-
San Juan, 푸에르토 리코, 00909
- 모병
- Latin Clinical Trial Center
-
-
-
-
New South Wales
-
Botany, New South Wales, 호주, 2019
- 모병
- Emeritus Research Sydney
-
Charlestown, New South Wales, 호주, 2290
- 모병
- Novatrials
-
Miranda, New South Wales, 호주, 2228
- 모병
- Canopy Clinical Sutherland
-
Miranda, New South Wales, 호주, 2228
- 모병
- Canopy Clinical Wollongong
-
-
Queensland
-
Meadowbrook, Queensland, 호주, 4131
- 모병
- Logan Hospital
-
-
SAU
-
Adelaide, SAU, 호주, 5000
- 모병
- Fusion Clinical Research
-
-
Victoria
-
Camberwell, Victoria, 호주, 3124
- 모병
- Emeritus Research Camberwell
-
North Altona, Victoria, 호주, 3025
- 모병
- Canopy Clinical Altona North
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
Administered subcutaneously
다른 이름들:
|
|
위약 비교기: 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. |
Administered subcutaneously. |
|
실험적: 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. |
Administered subcutaneously
다른 이름들:
|
|
실험적: 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. |
Administered subcutaneously
다른 이름들:
|
|
위약 비교기: 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. |
Administered subcutaneously. |
|
실험적: 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. |
Administered subcutaneously
다른 이름들:
|
|
실험적: 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. |
Administered subcutaneously
다른 이름들:
|
|
실험적: 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). |
Administered subcutaneously
다른 이름들:
|
|
실험적: 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). |
Administered subcutaneously
다른 이름들:
|
|
실험적: 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). |
Administered subcutaneously
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
기간: 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)
기간: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
기간: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
기간: 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
기간: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
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
- 20250197
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .