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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513539-25-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maridebart Cafraglutide | Experimental | Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maridebart Cafraglutide | Drug | Solution for subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 24 in Body Weight | Baseline to Week 24 | |
| Number of Participants Achieving HbA1c < 7.0% at Week 24 | Week 24 | |
| Number of Participants Achieving HbA1c ≤ 6.5% at Week 24 |
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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 |
|---|---|---|---|---|---|---|
| Accel Research Site - Birmingham Clinical Research Unit | Birmingham | Alabama | 35216 | United States | ||
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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 | Solution for subcutaneous injection. |
|
| Week 24 |
| Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24 | Week 24 |
| Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24 | Week 24 |
| Change From Baseline to Week 24 in Fasting Glucose | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Total Cholesterol | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Triglycerides | Baseline to Week 24 |
| Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) | Baseline and Week 24 |
| Change From Baseline to Week 24 in Systolic Blood Pressure | Baseline and Week 24 |
| Change From Baseline to Week 24 in Diastolic Blood Pressure | Baseline and Week 24 |
| Change from Baseline to Week 24 in High-sensitivity C-reactive Protein | Baseline and Week 24 |
| Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 | Week 20 |
| Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 | Week 20 |
| Number of Participants with Treatment Emergent Adverse Events | Up to 24 Weeks |
| Number of Participants with Serious Adverse Events | Up to 24 Weeks |
| Number of Participants with Anti-maridebart Cafraglutide Antibody Formation | Up to Week 24 |
| Anaheim Clinical Trials |
| Anaheim |
| California |
| 92801 |
| United States |
| Hope Clinical Research LLC | Canoga Park | California | 91303 | United States |
| Orange County Research Center | Lake Forest | California | 92630 | United States |
| San Jose Clinical Trials | San Jose | California | 95128 | United States |
| Northeast Research Institute - Neri | Fleming Island | Florida | 32003 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Florida Institute for Clinical Research | Orlando | Florida | 32825 | United States |
| Conquest Research - Winter Park | Winter Park | Florida | 32789 | United States |
| Accel Research Site - Neurostudies | Decatur | Georgia | 30030 | United States |
| Cedar Crosse Research and Health Care | Chicago | Illinois | 60607 | United States |
| Tandem Clinical Research - Marrero | Marrero | Louisiana | 70072 | United States |
| DM Clinical - Detroit | Southfield | Michigan | 48076 | United States |
| Montana Medical Research | Missoula | Montana | 59808 | United States |
| Physicians East | Greenville | North Carolina | 27834 | United States |
| Diabetes and Endocrinology Associates of Stark County Inc | Canton | Ohio | 44718 | United States |
| Alliance for Multispecialty Research | Norman | Oklahoma | 73069 | United States |
| Trial Management Associates - Myrtle Beach | Myrtle Beach | South Carolina | 29572 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Velocity Clinical Research - Dallas | Dallas | Texas | 75230 | United States |
| DM Clinical Research - Cyfair Clinical Research Center | Houston | Texas | 77065 | United States |
| Southern Endocrinology Associates PA | Mesquite | Texas | 75149 | United States |
| Be Well Clinical Studies | Round Rock | Texas | 78681 | United States |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | United States |
| Manassas Clinical Research Center Inc | Manassas | Virginia | 20110 | United States |
| Eastside Research Associates Health Research | Redmond | Washington | 98052 | United States |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Krankenhaus der Barmherzigen Brueder Linz | Linz | 4021 | Austria |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria |
| Klinik Hietzing | Vienna | 1130 | Austria |
| Laiko General Hospital of Athens | Athens | 11527 | Greece |
| Athens Medical Center S.A - Iatriko Amarousiou | Marousi | 15125 | Greece |
| Athens Medical Center- Iatriko Paleou Falirou | Palaió Fáliro | 17562 | Greece |
| Geniko Nosokomeio Peiraia Tzaneio | Piraeus | 18536 | Greece |
| General Hospital of Thessaloniki Ahepa | Thessaloniki | 54636 | Greece |
| Thermi Clinic S.A. | Thessaloniki | 57001 | Greece |
| Queen Mary Hospital, The University of Hong Kong | Hong Kong | Hong Kong |
| Lausmed Kft | Baja | 6500 | Hungary |
| Drug Research Center Kft | Balatonfüred | 8230 | Hungary |
| Szent Margit Rendelointezet Diabetologiai Ambulancia | Budapest | 1032 | Hungary |
| Clinexpert Kft | Budapest | 1033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft | Budapest | 1036 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| CRU Hungary Kft | Encs | 3860 | Hungary |
| Borbanya Praxis Egeszsegugyi Kft | Nyíregyháza | 4405 | Hungary |
| Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft | Zalaegerszeg | 8900 | Hungary |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari | Bari | 70124 | Italy |
| 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 |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco | Milan | 20157 | Italy |
| Kunisaki Makoto Clinic | Fukuoka | Fukuoka | 819-0168 | Japan |
| Nakamoto Medical Clinic | Mito | Ibaraki | 310-0826 | Japan |
| Ohishi Naika Clinic | Tsuchiura-shi | Ibaraki | 300-0835 | Japan |
| Morinaga Ueno Clinic | Kumamoto | Kumamoto | 860-0863 | Japan |
| Midori Clinic | Nagasaki | Nagasaki | 852-8034 | Japan |
| Shiraiwa Medical Clinic | Kashiwara-shi | Osaka | 582-0005 | Japan |
| Plumeria DM Clinic | Shizuoka | Shizuoka | 422-8006 | Japan |
| Yutenji Medical Clinic | Meguro-ku | Tokyo | 153-0053 | Japan |
| Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska | Bialystok | 15-435 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | 30-688 | Poland |
| Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii | Lublin | 20-090 | Poland |
| Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna | Staszów | 28-200 | Poland |
| Nbr Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska | Wroclaw | 51-162 | Poland |
| Futuremeds spolka z ograniczona odpowiedzialnoscia | Wroclaw | 53-673 | Poland |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| Mariodiab Clinic SRL | Brasov | 500101 | Romania |
| Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL | Bucharest | 011052 | Romania |
| Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu | Bucharest | 030167 | Romania |
| Consultmed SRL | Iași | 700544 | Romania |
| Clinica Korall | Satu Mare | 440055 | Romania |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | 13620 | 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 |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hospital Vithas Sevilla | Castilleja de la Cuesta | Andalusia | 41950 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital Universitario Arnau de Vilanova Lleida | Lleida | Catalonia | 25198 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Galicia | 15006 | Spain |
| Hospital Universitario de La Ribera | Alzira | Valencia | 46600 | Spain |
| Ostra Sjukhuset | Gothenburg | 416 85 | Sweden |
| Skanes universitetssjukhus | Lund | 222 42 | Sweden |
| Universitetssjukhuset Orebro | Örebro | 703 62 | Sweden |
| Sabbatsbergs Sjukhus | Stockholm | 113 61 | Sweden |
| Sodersjukhuset | Stockholm | 118 83 | Sweden |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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