DOR/ISL nei partecipanti naïve al trattamento antiretrovirale dell'HIV-1 (MK-8591A-053)
22 settembre 2026 aggiornato da: Merck Sharp & Dohme LLC
Uno studio clinico di fase 3, randomizzato, con controllo attivo, in doppio cieco per valutare l'attività antiretrovirale, la sicurezza e la tollerabilità di doravirina/islatravir (DOR/ISL 100 mg/0,25 mg) una volta al giorno in soggetti con infezione da HIV-1 naïve al trattamento Partecipanti
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
537
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, C1405CKC
- Fundación IDEAA ( Site 5851)
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Córdoba, Argentina, X5000JJS
- Instituto Oulton ( Site 5853)
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1427CEA
- Fundación Huésped ( Site 5850)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000PBJ
- Instituto CAICI SRL ( Site 5852)
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Ontario
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Hamilton, Ontario, Canada, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital ( Site 5753)
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Quebec
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Montreal, Quebec, Canada, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre ( Site 5751)
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Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
- Regina General Hospital ( Site 5754)
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Araucania
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Temuco, Araucania, Chile, 4781151
- Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Clinica Universidad Catolica del Maule ( Site 5954)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500710
- Biomedica Research Group-Infectology ( Site 5951)
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Santiago, Region M. de Santiago, Chile, 7770086
- Espacio Eme ( Site 5952)
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Santiago, Region M. de Santiago, Chile, 8330034
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
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Santiago, Region M. de Santiago, Chile, 8380420
- Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
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Atlántico
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Barranquilla, Atlántico, Colombia, 08001
- Ciensalud Ips S A S ( Site 6050)
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Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 6055)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110231
- Hospital Universitario San Ignacio-Infectious ( Site 6053)
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Bogotá, Bogota D.C., Colombia, 111321
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 6052)
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Paris, Francia, 75018
- Hôpital Bichat - Claude-Bernard ( Site 6162)
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Paris, Francia, 75571
- Hôpital Saint Antoine ( Site 6158)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
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Nord
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Tourcoing, Nord, Francia, 59200
- Tourcoing Hospital ( Site 6150)
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Île-de-France Region
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Bobigny, Île-de-France Region, Francia, 93000
- Hôpital Avicenne ( Site 6160)
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Paris, Île-de-France Region, Francia, 75010
- Hôpital Saint-Louis ( Site 6159)
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Paris, Île-de-France Region, Francia, 75013
- Pitie Salpetriere University Hospital ( Site 6156)
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Hamburg, Germania, 20146
- ICH Study Center GmbH & Co. KG ( Site 6259)
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Hamburg, Germania, 20246
- Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
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Bavaria
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München, Bavaria, Germania, 80336
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
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Brandenburg
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Freiburg, Brandenburg, Germania, 79106
- Universitaetsklinikum Freiburg ( Site 6256)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Germania, 53127
- Universitätsklinikum Bonn-Immunologie ( Site 6250)
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Osaka, Giappone, 540-0006
- National Hospital Organization Osaka National Hospital ( Site 6952)
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Aichi-ken
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Nagoya, Aichi-ken, Giappone, 460-0001
- National Hospital Organization Nagoya Medical Center ( Site 6953)
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Tokyo
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Shinjuku-ku, Tokyo, Giappone, 160-0023
- Tokyo Medical University Hospital ( Site 6954)
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Shinjyuku-ku, Tokyo, Giappone, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
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Guatemala City, Guatemala, 01001
- CLINIPHARM ( Site 8352)
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Guatemala City, Guatemala, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
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Guatemala City, Guatemala, 01010
- CELAN,S.A ( Site 8351)
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Haifa, Israele, 3109601
- Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
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Jerusalem, Israele, 9120
- Hadassah Medical Center-Infecious Disease ( Site 6752)
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Ramat Gan, Israele, 5262100
- Sheba Medical Center-HIV unit ( Site 6753)
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Tel Aviv, Israele, 6423906
- Sourasky Medical Center ( Site 6754)
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Kisumu, Kenya, 40100
- KEMRI-CMR-RCTP ( Site 8650)
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Nairobi City
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Nairobi, Nairobi City, Kenya, 00200
- CCR KEMRI (Center for Clinical Research) ( Site 8652)
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Nairobi, Nairobi City, Kenya, 00202
- PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur ( Site 7773)
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Kedah
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Alor Star, Kedah, Malaysia, 05460
- Hospital Sultanah Bahiyah ( Site 7776)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10450
- Hospital Pulau Pinang ( Site 7779)
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Sarawak
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Kuching, Sarawak, Malaysia, 93586
- Sarawak General Hospital ( Site 7772)
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang ( Site 7770)
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Sungai Buloh, Selangor, Malaysia, 47000
- Hospital Sungai Buloh ( Site 7778)
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Mexico City
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Mexico City, Mexico City, Messico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
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Ponce, Porto Rico, 00716
- Ponce Medical School Foundation Inc. ( Site 7452)
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San Juan, Porto Rico, 00909
- Clinical Research Puerto Rico ( Site 7450)
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San Juan, Porto Rico, 00909
- HOPE Clinical Research ( Site 7451)
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Bristol, City of
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Bristol, Bristol, City of, Regno Unito, BS10 5NB
- Southmead Hospital ( Site 7952)
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England
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London, England, Regno Unito, E1 1BB
- Royal London Hospital ( Site 7951)
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Manchester, England, Regno Unito, M13 0FH
- The Hathersage Centre ( Site 7953)
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London, City of
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London, London, City of, Regno Unito, SE5 9RL
- King's College Hospital ( Site 7950)
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London, London, City of, Regno Unito, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
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Santo Domingo Province
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Santo Domingo de Guzman, Santo Domingo Province, Repubblica Dominicana, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
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Barcelona, Spagna, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
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Madrid, Spagna, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
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Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
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Madrid, Spagna, 28046
- Hospital Universitario La Paz ( Site 6354)
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Málaga, Spagna, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
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Alicante
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Elche, Alicante, Spagna, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
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Barcelona
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Badalona, Barcelona, Spagna, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
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Catalonia
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Barcelona, Catalonia, Spagna, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
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L'Hospitalet de Llobregat,Barcelona, Catalonia, Spagna, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spagna, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
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Madrid, Madrid, Comunidad de, Spagna, 28034
- Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
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Arizona
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Phoenix, Arizona, Stati Uniti, 85015
- Pueblo Family Physicians ( Site 5674)
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California
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Beverly Hills, California, Stati Uniti, 90211
- Pacific Oaks Medical Group ( Site 5681)
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Los Angeles, California, Stati Uniti, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
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Colorado
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Denver, Colorado, Stati Uniti, 80246
- Vivent Health ( Site 5694)
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20017
- Washington Health Institute ( Site 5689)
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Florida
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Ft. Pierce, Florida, Stati Uniti, 34982
- Midway Immunology and Research Center ( Site 5657)
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Miami, Florida, Stati Uniti, 33133
- AHF The Kinder Medical Group ( Site 5672)
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Miami Beach, Florida, Stati Uniti, 33140
- AHF South Beach ( Site 5663)
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Orlando, Florida, Stati Uniti, 32803
- Orlando Immunology Center ( Site 5654)
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Sarasota, Florida, Stati Uniti, 34237
- CAN Community Health - Sarasota ( Site 5668)
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West Palm Beach, Florida, Stati Uniti, 33407
- Triple O Research Institute, P.A ( Site 5666)
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Georgia
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Atlanta, Georgia, Stati Uniti, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
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Atlanta, Georgia, Stati Uniti, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
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Atlanta, Georgia, Stati Uniti, 30309
- Atlanta I.D. Group ( Site 5680)
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Decatur, Georgia, Stati Uniti, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
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Macon, Georgia, Stati Uniti, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
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Chicago, Illinois, Stati Uniti, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
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Michigan
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Berkley, Michigan, Stati Uniti, 48072
- Be Well Medical Center ( Site 5650)
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital ( Site 5667)
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- Jubilee Clinical Research ( Site 5679)
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Las Vegas, Nevada, Stati Uniti, 89106
- Las Vegas Research Center ( Site 5691)
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New Jersey
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Hillsborough, New Jersey, Stati Uniti, 08844
- ID Care ( Site 5676)
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Newark, New Jersey, Stati Uniti, 07102
- Saint Michael's Medical Center ( Site 5682)
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
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The Bronx, New York, Stati Uniti, 10461
- Jacobi Medical Center ( Site 5683)
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
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Greensboro, North Carolina, Stati Uniti, 27401
- Regional Center for Infectious Diseases ( Site 5687)
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
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Texas
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Austin, Texas, Stati Uniti, 78705
- Central Texas Clinical Research ( Site 5661)
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Bellaire, Texas, Stati Uniti, 77401
- St Hope Foundation ( Site 5659)
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Dallas, Texas, Stati Uniti, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
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Dallas, Texas, Stati Uniti, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
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El Paso, Texas, Stati Uniti, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
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Fort Worth, Texas, Stati Uniti, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
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Longview, Texas, Stati Uniti, 75605
- DCOL Center for Clinical Research ( Site 5664)
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Free State
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Bloemfontein, Free State, Sud Africa, 9301
- Josha Research ( Site 6652)
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Gauteng
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Johannesburg, Gauteng, Sud Africa, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
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Johannesburg, Gauteng, Sud Africa, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
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Johannesburg, Gauteng, Sud Africa, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sud Africa, 4052
- Wentworth Hospital ( Site 6653)
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Ladysmith, KwaZulu-Natal, Sud Africa, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
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Pietermaritzburg, KwaZulu-Natal, Sud Africa, 3201
- Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
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North West
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Brits, North West, Sud Africa, 0250
- Madibeng Centre for Research ( Site 6660)
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Western Cape
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Cape Town, Western Cape, Sud Africa, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
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Cape Town, Western Cape, Sud Africa, 7925
- Desmond Tutu Health Foundation ( Site 6651)
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Paarl, Western Cape, Sud Africa, 7626
- Be Part Yoluntu Centre ( Site 6650)
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Canton of Basel-City
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Basel, Canton of Basel-City, Svizzera, 4031
- University Hospital Basel-Infectiology ( Site 8151)
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Canton of Geneva
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Geneva, Canton of Geneva, Svizzera, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
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Chiang Mai, Tailandia, 50200
- Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
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Bangkok
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Bangkok, Bangkok, Tailandia, 10330
- HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
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Bangkok, Bangkok, Tailandia, 10700
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
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Ankara
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Altindağ, Ankara, Turchia (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 7650)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
- Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
- If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Exclusion Criteria:
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
- Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks. |
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Altri nomi:
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
|
Comparatore attivo: BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks. |
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth. Placebo tablet matched to DOR/ISL tablet taken by mouth. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Lasso di tempo: Week 48
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
Lasso di tempo: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 48
Lasso di tempo: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Lasso di tempo: Week 96
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144
Lasso di tempo: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
Lasso di tempo: Week 48
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
Lasso di tempo: Week 96
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144
Lasso di tempo: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
Lasso di tempo: Baseline (Day 1) and Week 48
|
CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel. |
Baseline (Day 1) and Week 48
|
|
Change from baseline in CD4+ T-cells at Week 96
Lasso di tempo: Baseline (Day 1) and Week 96
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 96
|
|
Change from baseline in CD4+ T-cells at Week 144
Lasso di tempo: Baseline (Day 1) and Week 144
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 144
|
|
Incidence of viral drug resistance
Lasso di tempo: Up to 96 weeks
|
Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study. |
Up to 96 weeks
|
|
Change from baseline in body weight at Week 48
Lasso di tempo: Baseline (Day 1) and Week 48
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 48
|
|
Change from baseline in body weight at Week 96
Lasso di tempo: Baseline (Day 1) and Week 96
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 96
|
|
Change from baseline in body weight at Week 144
Lasso di tempo: Baseline (Day 1) and Week 144
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 144
|
|
Percentage of participants experiencing ≥1 AE through Week 144
Lasso di tempo: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 144
Lasso di tempo: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 marzo 2023
Completamento primario (Effettivo)
13 ottobre 2025
Completamento dello studio (Stimato)
5 agosto 2029
Date di iscrizione allo studio
Primo inviato
20 gennaio 2023
Primo inviato che soddisfa i criteri di controllo qualità
20 gennaio 2023
Primo Inserito (Effettivo)
30 gennaio 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 8591A-053
- 2022-502099-22-00 (Identificatore di registro: EU CT)
- jRCT2031220720 (Identificatore di registro: jRCT)
- U1111-1283-2516 (Identificatore di registro: UTN)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .