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).
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Amgen Call Center
- 電話番号：866-572-6436
- メール：medinfo@amgen.com
研究場所
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Alabama
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Anniston、Alabama、アメリカ、36207
- 募集
- Pinnacle Research Group LLC
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Daphne、Alabama、アメリカ、36526
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- Alliance For Multispecialty Research - Daphne
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Mobile、Alabama、アメリカ、36608
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- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley、California、アメリカ、92708
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- Ark Clinical Research- Tustin
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Long Beach、California、アメリカ、90806
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- Long Beach Clinical Trials Services Inc
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Long Beach、California、アメリカ、90815
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- Ark Clinical Research- Long Beach
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Montclair、California、アメリカ、91763
- 募集
- Catalina Research Institute
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Riverside、California、アメリカ、92503
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- Artemis Institute for Clinical Research
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San Diego、California、アメリカ、92103
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- Artemis Institute for Clinical Research
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San Diego、California、アメリカ、92120
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- Apex Clinical Research
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Santa Ana、California、アメリカ、92701
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- Southern California Clinical Research
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Walnut Creek、California、アメリカ、94598
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- Diablo Clinical Research
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Connecticut
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Waterbury、Connecticut、アメリカ、06708
- 募集
- Chase Medical Research LLC
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Florida
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Jacksonville、Florida、アメリカ、32216
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- Jacksonville Center for Clinical Research
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Jacksonville、Florida、アメリカ、32256
- 募集
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill、Florida、アメリカ、33351
- 募集
- South Florida Wellness and Clinical Research Institute
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Miami、Florida、アメリカ、33173
- 募集
- Research Institute of South Florida
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Miami、Florida、アメリカ、33135
- 募集
- Optimus U Corporation
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Miami Lakes、Florida、アメリカ、33016
- 募集
- Indago Research and Health Center
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Ocala、Florida、アメリカ、34470
- 募集
- Renstar Medical Research
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Orlando、Florida、アメリカ、32801
- 募集
- Clinical Neuroscience Solutions - Orlando
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Orlando、Florida、アメリカ、32825
- 募集
- Florida Institute for Clinical Research
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Orlando、Florida、アメリカ、32807
- 募集
- Combined Research Orlando Phase I IV
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Weston、Florida、アメリカ、33331
- 募集
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville、Georgia、アメリカ、30501
- 募集
- Center for Advanced Research and Education
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Union City、Georgia、アメリカ、30291
- 募集
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu、Hawaii、アメリカ、96814
- 募集
- East-West Medical Research
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Idaho
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Meridian、Idaho、アメリカ、83646
- 募集
- Solaris Clinical Research
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Illinois
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Chicago、Illinois、アメリカ、60640
- 募集
- Flourish Research - Great Lakes Clinical Trials
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Skokie、Illinois、アメリカ、60077
- 募集
- Evanston Premier Healthcare Research LLC
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Skokie、Illinois、アメリカ、60077
- 募集
- Endeavor Health
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Kansas
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Lenexa、Kansas、アメリカ、66219
- 募集
- JCCT- Juno Northwest Houston
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Newton、Kansas、アメリカ、67114
- 募集
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville、Kentucky、アメリカ、40213
- 募集
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70809
- 募集
- Velocity Clinical Research - Baton Rouge
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Marrero、Louisiana、アメリカ、70072
- 募集
- Tandem Clinical Research - Marrero
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Michigan
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Southfield、Michigan、アメリカ、48034
- 募集
- Headlands Research - Detroit
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Mississippi
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Fayette、Mississippi、アメリカ、39069
- 募集
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City、Missouri、アメリカ、64114
- 募集
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas、Nevada、アメリカ、89128
- 募集
- Vector Clinical Trials
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Las Vegas、Nevada、アメリカ、89148
- 募集
- Palm Research Center Inc
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New York
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Binghamton、New York、アメリカ、13905
- 募集
- Velocity Clinical Research- Binghamton
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Rochester、New York、アメリカ、14609
- 募集
- Rochester Clinical Research
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North Carolina
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Hickory、North Carolina、アメリカ、28602
- 募集
- Accellacare of Hickory
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Shelby、North Carolina、アメリカ、28150
- 募集
- Carolina Research Center Inc
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- 募集
- Velocity Clinical Research - Cincinnati
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Cincinnati、Ohio、アメリカ、45212
- 募集
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman、Oklahoma、アメリカ、73069
- 募集
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport、Pennsylvania、アメリカ、17074
- 募集
- Capital Area Research LLC
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Rhode Island
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East Greenwich、Rhode Island、アメリカ、02818
- 募集
- Velocity Clinical Research - Providence
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South Carolina
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Greenville、South Carolina、アメリカ、29607
- 募集
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville、Tennessee、アメリカ、37909
- 募集
- New Phase Research and Development
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Knoxville、Tennessee、アメリカ、37938
- 募集
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin、Texas、アメリカ、78704
- 募集
- Elligo Clinical Research Center
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Bellaire、Texas、アメリカ、77401
- 募集
- Johnson County Clinical Trials Juno Bellaire
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Dallas、Texas、アメリカ、75251
- 募集
- Cedar Health Research, LLC
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Dallas、Texas、アメリカ、75235
- 募集
- Cedar Health Research, LLC
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DeSoto、Texas、アメリカ、75115
- 募集
- Epic Medical Research - Red Oak
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El Paso、Texas、アメリカ、79905
- 募集
- Great Lakes Research Institute El Paso Research
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Houston、Texas、アメリカ、77043
- 募集
- Biopharma Informatic, LLC
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Mesquite、Texas、アメリカ、75149
- 募集
- Southern Endocrinology Associates PA
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Pharr、Texas、アメリカ、78557
- 募集
- Great Lakes Research Institute - McAllen Research
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San Antonio、Texas、アメリカ、78229
- 募集
- Clinical Trials of Texas
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Sugar Land、Texas、アメリカ、77479
- 募集
- Sugar Lakes Family Practice
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Utah
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Bountiful、Utah、アメリカ、84010
- 募集
- Pantheon Clinical Research
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Layton、Utah、アメリカ、84041
- 募集
- Alliance for Multispecialty Research Layton Research Center
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St. George、Utah、アメリカ、84790
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- Chrysalis Clinical Research, LLC
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Virginia
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Arlington、Virginia、アメリカ、22206
- 募集
- Washington Center for Weight Management and Research, Inc
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Newport News、Virginia、アメリカ、23606
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- Health Research of Hampton Roads
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Winchester、Virginia、アメリカ、22601
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- Selma Medical Associates
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Wisconsin
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Wauwatosa、Wisconsin、アメリカ、53226
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- Allegiance Research Specialists
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New South Wales
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Botany、New South Wales、オーストラリア、2019
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- Emeritus Research Sydney
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Charlestown、New South Wales、オーストラリア、2290
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- Novatrials
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Miranda、New South Wales、オーストラリア、2228
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- Canopy Clinical Sutherland
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Miranda、New South Wales、オーストラリア、2228
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- Canopy Clinical Wollongong
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Queensland
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Meadowbrook、Queensland、オーストラリア、4131
- 募集
- Logan Hospital
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SAU
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Adelaide、SAU、オーストラリア、5000
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- Fusion Clinical Research
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Victoria
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Camberwell、Victoria、オーストラリア、3124
- 募集
- Emeritus Research Camberwell
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North Altona、Victoria、オーストラリア、3025
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- Canopy Clinical Altona North
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Ontario
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Hamilton、Ontario、カナダ、L8L 5G8
- 募集
- Wharton Medical Clinic
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Thunder Bay、Ontario、カナダ、P7B 6V4
- 募集
- Curans Heart Center
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Quebec
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Chicoutimi、Quebec、カナダ、G7H 7K9
- 募集
- Ecogene-21
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Ponce、プエルトリコ、00716
- 募集
- Ponce Medical School Foundation Inc
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Ponce、プエルトリコ、00717
- 募集
- Puerto Rico Medical Research Inc.
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San Juan、プエルトリコ、00909
- 募集
- Latin Clinical Trial Center
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Kanagawa
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Yokohama、Kanagawa、日本、231-0023
- 募集
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku、Tokyo、日本、101-0041
- 募集
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku、Tokyo、日本、104-0031
- 募集
- Tokyo Asbo Clinic
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Hachioji-shi、Tokyo、日本、192-0046
- 募集
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku、Tokyo、日本、108-0075
- 募集
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku、Tokyo、日本、160-0004
- 募集
- Clinical Research Hospital Tokyo
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Suginami-ku、Tokyo、日本、166-0003
- 募集
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
|
プラセボコンパレーター：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. |
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
|
プラセボコンパレーター：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. |
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
時間枠：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)
時間枠：Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
時間枠：Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
時間枠：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
時間枠：Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：MD、Amgen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20250197
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。