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The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maridebart Cafraglutide High Dose | Experimental | Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. |
|
| Maridebart Cafraglutide Medium Dose | Experimental | Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. |
|
| Maridebart Cafraglutide Low Dose | Experimental | Participants will receive maridebart cafraglutide low dose SC for 72 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo SC for 72 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maridebart cafraglutide | Drug | Maridebart cafraglutide will be adminstered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Waist Circumference at Week 72 | Baseline and Week 72 | |
| Participant achieving ≥ 5% reduction in body weight from baseline at week 72 | Baseline and Week 72 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research Mobile | Mobile | Alabama | 36608 | United States | ||
| Gilbert Center for Family Medicine |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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|
| Placebo | Drug | Placebo will be adminstered SC. |
|
| Participant achieving ≥ 10% reduction in body weight from baseline at week 72 |
| Baseline and Week 72 |
| Participant achieving ≥ 15% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in Fasting Triglycerides at Week 72 | Baseline and Week 72 |
| Change from Baseline in Fasting Plasma Glucose at Week 72 | Baseline and Week 72 |
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 | Baseline and Week 72 |
| Participant achieving HbA1c < 7% at week 72 | Week 72 |
| Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 | Baseline and Week 72 |
| Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
| Participant achieving ≥ 20% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Change from Baseline in Body Mass Index (BMI) at Week 72 | Baseline and Week 72 |
| Participant achieving HbA1c ≤ 6.5% at week 72 | Week 72 |
| Participant achieving HbA1c < 5.7%, at week 72 | Week 72 |
| Percent Change from Baseline in Fasting Insulin at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 | Baseline and Week 72 |
| Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C) | Baseline and Week 72 |
| Change from Baseline in Diastolic Blood Pressure DBP at Week 72 | Baseline and Week 72 |
| Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 | Baseline and Week 72 |
| Number of Participants who Experienced Treatment-emergent Adverse Events | Up to Week 84 |
| Number of Participants who Experienced Serious Adverse Events | Up to Week 84 |
| Plasma Concentration of Maridebart Cafraglutide at Week 72 | Week 72 |
| Gilbert |
| Arizona |
| 85296 |
| United States |
| Desert Clinical Research | Mesa | Arizona | 85213 | United States |
| Avacare Foothills Research Center | Phoenix | Arizona | 85044 | United States |
| San Fernando Valley Health Institute | Canoga Park | California | 91304 | United States |
| Core Healthcare Group | Cerritos | California | 90703 | United States |
| Velocity Clinical Research Chula Vista | Chula Vista | California | 91911 | United States |
| Headlands Research California | Escondido | California | 92025 | United States |
| Paradigm Clinical Research | Modesto | California | 95355 | United States |
| Flourish Research | Northridge | California | 91325 | United States |
| University of California Irvine | Orange | California | 92868 | United States |
| Empire Clinical Research | Pomona | California | 91767 | United States |
| Infinity Clinical Trials | San Diego | California | 92108 | United States |
| Greenwich Clinical Trials | Riverside | Connecticut | 06878 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Optimus U Corporation | Miami | Florida | 33135 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| San Marcus Research Clinic Inc | Miami Lakes | Florida | 33014 | United States |
| Florida Institute for Clinical Research | Orlando | Florida | 32825 | United States |
| Encore Medical Research of Weston LLC | Weston | Florida | 33331 | United States |
| Conquest Research - Winter Park | Winter Park | Florida | 32789 | United States |
| Alliance For Multispecialty Research - Oak Brook | Oak Brook | Illinois | 60523 | United States |
| Alliance for Multispecialty Research, LLC - Park Ridge | Park Ridge | Illinois | 66068 | United States |
| Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie | Skokie | Illinois | 60077 | United States |
| Indiana Medical Research Institute | Merrillville | Indiana | 46410 | United States |
| Iowa Diabetes Research | West Des Moines | Iowa | 50266 | United States |
| Alliance for Multispecialty Research Newton | Newton | Kansas | 67114 | United States |
| Alliance for Multispecialty Research LLC | Wichita | Kansas | 67207 | United States |
| Advanced Internal Medicine | Paducah | Kentucky | 42001 | United States |
| Ima Clinical Research- Monroe | Monroe | Louisiana | 71201 | United States |
| Annapolis Internal Medicine, LLC | Annapolis | Maryland | 21401 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| International Diabetes Center - HealthPartners Institute | Minneapolis | Minnesota | 55416 | United States |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri | 64114 | United States |
| Palm Research Center Inc | Las Vegas | Nevada | 89128 | United States |
| Vector Clinical Trials | Sparks | Nevada | 89436 | United States |
| Premier Research | Trenton | New Jersey | 08611 | United States |
| Albany Medical College | Albany | New York | 12203 | United States |
| Asheville Clinical Research | Asheville | North Carolina | 28803 | United States |
| Physicians East | Greenville | North Carolina | 27834 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| West Clinical Research | Morehead City | North Carolina | 28557 | United States |
| Velocity Clinical Research - Cincinnati | Blue Ash | Ohio | 45242 | United States |
| Velocity Clinical Research - Springdale | Cincinnati | Ohio | 45246 | United States |
| Velocity Clinical Research - Providence | East Greenwich | Rhode Island | 02818 | United States |
| Medical Care LLC | Elizabethton | Tennessee | 37643 | United States |
| Elligo Clinical Research Center | Austin | Texas | 78701 | United States |
| Osvaldo A Brusco MD PA | Corpus Christi | Texas | 78414 | United States |
| Cedar Health Research, LLC | Dallas | Texas | 75251 | United States |
| Soma Clinical Trials, LLC | Denison | Texas | 75020 | United States |
| Cedar Health Research, LLC | Euless | Texas | 76040 | United States |
| Juno Research LLC | Houston | Texas | 77040 | United States |
| Juno Research LLC | Houston | Texas | 77054 | United States |
| Tekton Research | McKinney | Texas | 75069 | United States |
| Northeast Clinical Research of San Antonio LLC | San Antonio | Texas | 78233 | United States |
| Alliance for Multispecialty Research - Layton | Layton | Utah | 84041 | United States |
| Manassas Clinical Research Center Inc | Manassas | Virginia | 20110 | United States |
| VA Puget Sound Healthcare System | Seattle | Washington | 98108 | United States |
| Ima Clinical Research - West Virginia | Morgantown | West Virginia | 26505 | United States |
| Centro Medico Viamonte | CABA | Buenos Aires | 1120 | Argentina |
| Cedic Centro de Investigacion Clinica | CABA | Buenos Aires | C1060ABN | Argentina |
| Cemedic Centro de Especialidades Medicas | CABA | Buenos Aires | C1407GTN | Argentina |
| Maffei Centro Medico | CABA | Buenos Aires | C1425AGC | Argentina |
| Consultorios Medicos Dr Besada | CABA | Buenos Aires | C1426ABP | Argentina |
| Cinme - Centro de Investigaciones Metabolicas | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1056ABI | Argentina |
| Ciprec Centro de Investigacion y Prevencion Cardiovascular | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1061AAT | Argentina |
| Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD | Pleven | 5801 | Bulgaria |
| Diagnostic - Consultative Center XX - Sofia EOOD | Sofia | 1404 | Bulgaria |
| Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sofiamed OOD | Sofia | 1750 | Bulgaria |
| Prevencia-2000-Medical center for outpatient medical aid OOD | Stara Zagora | 6000 | Bulgaria |
| Medical Center Berbatov EOOD | Yambol | 8600 | Bulgaria |
| tlc Diabetes and Endocrinology | Surrey | British Columbia | V3T 2V6 | Canada |
| Chronic Disease Innovation Centre | Winnipeg | Manitoba | R2V 3M3 | Canada |
| Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Centricity Research Brampton | Brampton | Ontario | L6S 0C6 | Canada |
| Aggarwal and Associates Ltd | Brampton | Ontario | L6T 0G1 | Canada |
| Centricity Research Vaughan | Concord | Ontario | L4K 4M2 | Canada |
| Winterberry Family Medicine | Hamilton | Ontario | L8J 0B6 | Canada |
| Premier Clinical Trial Network | Hamilton | Ontario | L8L 5G4 | Canada |
| Milestone Research | London | Ontario | N5W 6A2 | Canada |
| Centricity Research Ottawa LMC | Nepean | Ontario | K2J 0V2 | Canada |
| Your Research Network Inc. | Niagara Falls | Ontario | L2H 1H5 | Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B 3H7 | Canada |
| Bluewater Clinical Research Group Incorporated | Sarnia | Ontario | N7T 4X3 | Canada |
| Albion Finch Medical Centre | Toronto | Ontario | M9V 4B4 | Canada |
| Centricity Research Quebec City | Lévis | Quebec | G6W 0M5 | Canada |
| Institut de recherches cliniques de Montreal | Montreal | Quebec | H2W 1R7 | Canada |
| Centre Medical Acadie | Montreal | Quebec | H4N 2W2 | Canada |
| Centricity Research Pointe-Claire | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Diex Recherche Trois Rivieres | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| CCR Ostrava sro | Ostrava | 702 00 | Czechia |
| Diahelp sro | Pardubice | 530 02 | Czechia |
| Pratia Pardubice as | Pardubice | 530 02 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Institut klinicke a experimentalni mediciny | Prague | 140 21 | Czechia |
| Milan Kvapil sro | Prague | 149 00 | Czechia |
| Restrial sro | Prague | 181 00 | Czechia |
| Endokrinologie Cerny Most sro | Prague | 198 00 | Czechia |
| Milan Kvapil sro | Pribram VIII | 261 01 | Czechia |
| Universitatsklinikum Aachen | Aachen | 52074 | Germany |
| Universitaets-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Diabetespraxis Bad Mergentheim | Bad Mergentheim | 97980 | Germany |
| Universitaetsklinikum der Ruhr-Universitaet Bochum | Bad Oeynhausen | 32545 | Germany |
| Charite - Universitaetsmedizin Berlin, Campus Mitte | Berlin | 10117 | Germany |
| Velocity Clinical Research GmbH | Berlin | 10787 | Germany |
| Diabetespraxis Dr. Hermann Braun | Berlin | 13187 | Germany |
| Mvz am Bahnhof Spandau | Berlin | 13597 | Germany |
| Zentrum fuer Klinische Studien Suedbrandenburg GmbH | Elsterwerda | 04910 | Germany |
| InnoDiab Forschung | Essen | 45136 | Germany |
| Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin | Falkensee | 14612 | Germany |
| Diabeteszentrum Hamburg West | Hamburg | 22607 | Germany |
| Endokrinologikum Hamburg | Hamburg | 22767 | Germany |
| Diabetologische Schwerpunktpraxis Hohenmoelsen | Hohenmölsen | 06679 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| AmBeNet GmbH | Leipzig | 04107 | Germany |
| Kardiologische Praxis Doktor Jens Taggeselle | Markkleeberg | 04416 | Germany |
| Centrum für Diagnostik und Gesundheit | München | 80809 | Germany |
| Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster | Münster | 48145 | Germany |
| Red-Institut GmbH | Oldenburg | 23758 | Germany |
| Lausmed Kft | Baja | 6500 | Hungary |
| DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | 8230 | Hungary |
| Clinexpert Kft | Budapest | 1033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| ClinDiab Kft | Budapest | 1089 | Hungary |
| MED-TIMA Kft | Budapest | 1132 | Hungary |
| Borvo Clinic Kft | Debrecen | 4025 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Komaromi Selye Janos Korhaz | Komárom | 2900 | Hungary |
| Borbanya Praxis Egeszsegugyi Kft | Nyíregyháza | 4405 | Hungary |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz | Szombathely | 9700 | Hungary |
| IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola | Bologna | 40138 | Italy |
| Universita degli Studi Gabriele D Annunzio di Chieti e Pescara | Chieti | 66100 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| IRCCS Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco | Milan | 20157 | Italy |
| Ospedale Civico, Di Cristina e Benfratelli | Palermo | 90127 | Italy |
| Mikannohana Clinic, Diabetes, Endocrinology and Metabolism | Matsuyama | Ehime | 790-0034 | Japan |
| Morizono Medical Clinic | Kitakyusyu-shi | Fukuoka | 807-0072 | Japan |
| Mazda Hospital of Mazda Motor Corporation | Aki-gun | Hiroshima | 735-8585 | Japan |
| Nakamoto Medical Clinic | Mito | Ibaraki | 310-0826 | Japan |
| Nakakinen Clinic | Naka | Ibaraki | 311-0113 | Japan |
| Ohishi Naika Clinic | Tsuchiura-shi | Ibaraki | 300-0835 | Japan |
| Morinaga Ueno Clinic | Kumamoto | Kumamoto | 860-0863 | Japan |
| Shiraiwa Medical Clinic | Kashiwara-shi | Osaka | 582-0005 | Japan |
| Suruga Clinic | Shizuoka | Shizuoka | 424-0855 | Japan |
| Yutenji Medical Clinic | Meguro-ku | Tokyo | 153-0053 | Japan |
| Medical Corporation Ouitsukai Kanno Naika | Mitaka-shi | Tokyo | 181-0013 | Japan |
| Salvia-Lekston i Madej Spolka Jawna | Katowice | 40-772 | Poland |
| Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna | Lodz | 90-338 | Poland |
| Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski | Lublin | 20-011 | Poland |
| Ekamed Spolka z Ograniczona Odpowiedzialnoscia | Lublin | 20-718 | Poland |
| Medicome Spolka z Ograniczona Odpowiedzialnoscia | Oświęcim | 32-600 | Poland |
| Velocity Nova Sp zoo Velocity Pulawy | Puławy | 24-100 | Poland |
| NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna | Ruda Śląska | 41-709 | Poland |
| Velocity Nova Sp zoo Velocity Staszow | Staszów | 28-200 | Poland |
| Tomasz Blicharski Lubelskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
| Nbr Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warsaw | 02-507 | Poland |
| Wromedica I Bielicka A Strzalkowska SC | Wroclaw | 51-685 | Poland |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| Korea University Ansan Hospital | Ansan-si, Gyeonggi-do | 15355 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| KyungHee University Gangdong Hospital | Seoul | 05278 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wonju-si, Gangwon-do | 26426 | South Korea |
| Ormeau Clinical Trials Ltd | Belfast | BT28BG | United Kingdom |
| FutureMeds Birmingham | Birmingham | B21 9RY | United Kingdom |
| Layton Medical Centre | Blackpool | FY3 7EN | United Kingdom |
| Waterloo Medical Centre | Blackpool | FY4 3AD | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Staploe Medical Centre | Ely | CB7 5JD | United Kingdom |
| FutureMeds Glasgow | Glasgow | G20 7BE | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre | Leicester | LE5 4PW | United Kingdom |
| Aintree University Hospital | Liverpool | L9 7AL | United Kingdom |
| Clifton Medical Centre | Rotherham | S65 1DA | United Kingdom |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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