此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

HIV-1 抗逆转录病毒治疗初治参与者的 DOR/ISL (MK-8591A-053)

2026年9月22日 更新者：Merck Sharp & Dohme LLC

一项评估 Doravirine/Islatravir（DOR/ISL 100 mg/0.25 mg）每日一次在 HIV-1 感染者治疗初治患者中的抗逆转录病毒活性、安全性和耐受性的 3 期随机、主动控制、双盲临床研究参加者

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.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

537

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Haifa、以色列、3109601
        • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
      • Jerusalem、以色列、9120
        • Hadassah Medical Center-Infecious Disease ( Site 6752)
      • Ramat Gan、以色列、5262100
        • Sheba Medical Center-HIV unit ( Site 6753)
      • Tel Aviv、以色列、6423906
        • Sourasky Medical Center ( Site 6754)
  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8S 1A4
        • Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
      • Toronto、Ontario、加拿大、M5G 2C4
        • Toronto General Hospital ( Site 5753)
    • Quebec
      • Montreal、Quebec、加拿大、H2L 4P9
        • Clinique Medicale lActuel ( Site 5752)
      • Montreal、Quebec、加拿大、H4A 3J1
        • McGill University Health Centre ( Site 5751)
    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4P 0W5
        • Regina General Hospital ( Site 5754)
  • 南非
    • Free State
      • Bloemfontein、Free State、南非、9301
        • Josha Research ( Site 6652)
    • Gauteng
      • Johannesburg、Gauteng、南非、2013
        • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
      • Johannesburg、Gauteng、南非、2092
        • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
      • Johannesburg、Gauteng、南非、2193
        • Ezintsha-Clinical Research Site ( Site 6656)
    • KwaZulu-Natal
      • Durban、KwaZulu-Natal、南非、4052
        • Wentworth Hospital ( Site 6653)
      • Ladysmith、KwaZulu-Natal、南非、3370
        • Qhakaza Mbokodo Research Clinic ( Site 6659)
      • Pietermaritzburg、KwaZulu-Natal、南非、3201
        • Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
    • North West
      • Brits、North West、南非、0250
        • Madibeng Centre for Research ( Site 6660)
    • Western Cape
      • Cape Town、Western Cape、南非、7500
        • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
      • Cape Town、Western Cape、南非、7925
        • Desmond Tutu Health Foundation ( Site 6651)
      • Paarl、Western Cape、南非、7626
        • Be Part Yoluntu Centre ( Site 6650)
  • 危地马拉
      • Guatemala City、危地马拉、01001
        • CLINIPHARM ( Site 8352)
      • Guatemala City、危地马拉、01009
        • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
      • Guatemala City、危地马拉、01010
        • CELAN,S.A ( Site 8351)
  • 哥伦比亚
    • Atlántico
      • Barranquilla、Atlántico、哥伦比亚、08001
        • Ciensalud Ips S A S ( Site 6050)
      • Barranquilla、Atlántico、哥伦比亚、080020
        • Clinica de la Costa S.A.S. ( Site 6055)
    • Bogota D.C.
      • Bogotá、Bogota D.C.、哥伦比亚、110231
        • Hospital Universitario San Ignacio-Infectious ( Site 6053)
      • Bogotá、Bogota D.C.、哥伦比亚、111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760032
        • Fundación Valle del Lili ( Site 6052)
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06800
        • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
    • Ankara
      • Altindağ、Ankara、土耳其（türkiye）、06230
        • Hacettepe Universite Hastaneleri ( Site 7650)
  • 墨西哥
    • Mexico City
      • Mexico City、Mexico City、墨西哥、14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
  • 多明尼加共和国
    • Santo Domingo Province
      • Santo Domingo de Guzman、Santo Domingo Province、多明尼加共和国、10305
        • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
  • 德国
      • Hamburg、德国、20146
        • ICH Study Center GmbH & Co. KG ( Site 6259)
      • Hamburg、德国、20246
        • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
    • Bavaria
      • München、Bavaria、德国、80336
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
    • Brandenburg
      • Freiburg、Brandenburg、德国、79106
        • Universitaetsklinikum Freiburg ( Site 6256)
    • North Rhine-Westphalia
      • Bonn、North Rhine-Westphalia、德国、53127
        • Universitätsklinikum Bonn-Immunologie ( Site 6250)
  • 日本
      • Osaka、日本、540-0006
        • National Hospital Organization Osaka National Hospital ( Site 6952)
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 6953)
    • Tokyo
      • Shinjuku-ku、Tokyo、日本、160-0023
        • Tokyo Medical University Hospital ( Site 6954)
      • Shinjyuku-ku、Tokyo、日本、162-8655
        • Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
  • 智利
    • Araucania
      • Temuco、Araucania、智利、4781151
        • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
    • Maule Region
      • Talca、Maule Region、智利、3465584
        • Clinica Universidad Catolica del Maule ( Site 5954)
    • Region M. de Santiago
      • Santiago、Region M. de Santiago、智利、7500710
        • Biomedica Research Group-Infectology ( Site 5951)
      • Santiago、Region M. de Santiago、智利、7770086
        • Espacio Eme ( Site 5952)
      • Santiago、Region M. de Santiago、智利、8330034
        • Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
      • Santiago、Region M. de Santiago、智利、8380420
        • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
  • 法国
      • Paris、法国、75018
        • Hôpital Bichat - Claude-Bernard ( Site 6162)
      • Paris、法国、75571
        • Hôpital Saint Antoine ( Site 6158)
    • Alpes-Maritimes
      • Nice、Alpes-Maritimes、法国、06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
    • Nord
      • Tourcoing、Nord、法国、59200
        • Tourcoing Hospital ( Site 6150)
    • Île-de-France Region
      • Bobigny、Île-de-France Region、法国、93000
        • Hôpital Avicenne ( Site 6160)
      • Paris、Île-de-France Region、法国、75010
        • Hôpital Saint-Louis ( Site 6159)
      • Paris、Île-de-France Region、法国、75013
        • Pitie Salpetriere University Hospital ( Site 6156)
  • 波多黎各
      • Ponce、波多黎各、00716
        • Ponce Medical School Foundation Inc. ( Site 7452)
      • San Juan、波多黎各、00909
        • Clinical Research Puerto Rico ( Site 7450)
      • San Juan、波多黎各、00909
        • HOPE Clinical Research ( Site 7451)
  • 泰国
      • Chiang Mai、泰国、50200
        • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
    • Bangkok
      • Bangkok、Bangkok、泰国、10330
        • HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
      • Bangkok、Bangkok、泰国、10700
        • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
  • 瑞士
    • Canton of Basel-City
      • Basel、Canton of Basel-City、瑞士、4031
        • University Hospital Basel-Infectiology ( Site 8151)
    • Canton of Geneva
      • Geneva、Canton of Geneva、瑞士、1205
        • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85015
        • Pueblo Family Physicians ( Site 5674)
    • California
      • Beverly Hills、California、美国、90211
        • Pacific Oaks Medical Group ( Site 5681)
      • Los Angeles、California、美国、90036
        • Ruane Clinical Research Group, Inc ( Site 5658)
    • Colorado
      • Denver、Colorado、美国、80246
        • Vivent Health ( Site 5694)
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20017
        • Washington Health Institute ( Site 5689)
    • Florida
      • Ft. Pierce、Florida、美国、34982
        • Midway Immunology and Research Center ( Site 5657)
      • Miami、Florida、美国、33133
        • AHF The Kinder Medical Group ( Site 5672)
      • Miami Beach、Florida、美国、33140
        • AHF South Beach ( Site 5663)
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center ( Site 5654)
      • Sarasota、Florida、美国、34237
        • CAN Community Health - Sarasota ( Site 5668)
      • West Palm Beach、Florida、美国、33407
        • Triple O Research Institute, P.A ( Site 5666)
    • Georgia
      • Atlanta、Georgia、美国、30308
        • Emory University and Grady Health System-Medicine ( Site 5690)
      • Atlanta、Georgia、美国、30308
        • Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
      • Atlanta、Georgia、美国、30309
        • Atlanta I.D. Group ( Site 5680)
      • Decatur、Georgia、美国、30033
        • Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
      • Macon、Georgia、美国、31201
        • Mercer University, Department of Internal Medicine ( Site 5655)
    • Illinois
      • Chicago、Illinois、美国、60612
        • Rush University Medical Center-Infectious Disease ( Site 5671)
      • Chicago、Illinois、美国、60612
        • University of Illinois at Chicago-Project WISH ( Site 5685)
      • Chicago、Illinois、美国、60613
        • Howard Brown Health Center-Clinical Research ( Site 5665)
    • Michigan
      • Berkley、Michigan、美国、48072
        • Be Well Medical Center ( Site 5650)
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital ( Site 5667)
    • Missouri
      • Kansas City、Missouri、美国、64111
        • KC CARE Health Center-Clinical Trials ( Site 5670)
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • Jubilee Clinical Research ( Site 5679)
      • Las Vegas、Nevada、美国、89106
        • Las Vegas Research Center ( Site 5691)
    • New Jersey
      • Hillsborough、New Jersey、美国、08844
        • ID Care ( Site 5676)
      • Newark、New Jersey、美国、07102
        • Saint Michael's Medical Center ( Site 5682)
    • New York
      • New York、New York、美国、10032
        • Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
      • The Bronx、New York、美国、10461
        • Jacobi Medical Center ( Site 5683)
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
      • Greensboro、North Carolina、美国、27401
        • Regional Center for Infectious Diseases ( Site 5687)
    • Ohio
      • Cincinnati、Ohio、美国、45267-0405
        • University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
    • Texas
      • Austin、Texas、美国、78705
        • Central Texas Clinical Research ( Site 5661)
      • Bellaire、Texas、美国、77401
        • St Hope Foundation ( Site 5659)
      • Dallas、Texas、美国、75208
        • Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
      • Dallas、Texas、美国、75246
        • North Texas Infectious Diseases Consultants, P.A ( Site 5651)
      • El Paso、Texas、美国、79902
        • AXCES Research - Texas - El Paso ( Site 5692)
      • Fort Worth、Texas、美国、76104
        • Texas Centers for Infectious Disease Associates ( Site 5656)
      • Longview、Texas、美国、75605
        • DCOL Center for Clinical Research ( Site 5664)
  • 肯尼亚
      • Kisumu、肯尼亚、40100
        • KEMRI-CMR-RCTP ( Site 8650)
    • Nairobi City
      • Nairobi、Nairobi City、肯尼亚、00200
        • CCR KEMRI (Center for Clinical Research) ( Site 8652)
      • Nairobi、Nairobi City、肯尼亚、00202
        • PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
  • 英国
    • Bristol, City of
      • Bristol、Bristol, City of、英国、BS10 5NB
        • Southmead Hospital ( Site 7952)
    • England
      • London、England、英国、E1 1BB
        • Royal London Hospital ( Site 7951)
      • Manchester、England、英国、M13 0FH
        • The Hathersage Centre ( Site 7953)
    • London, City of
      • London、London, City of、英国、SE5 9RL
        • King's College Hospital ( Site 7950)
      • London、London, City of、英国、WC1E 6JB
        • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
      • Madrid、西班牙、28015
        • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre ( Site 6355)
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz ( Site 6354)
      • Málaga、西班牙、29010
        • Hospital Universitario Virgen de la Victoria ( Site 6359)
    • Alicante
      • Elche、Alicante、西班牙、03202
        • Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
    • Catalonia
      • Barcelona、Catalonia、西班牙、08036
        • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
      • L'Hospitalet de Llobregat,Barcelona、Catalonia、西班牙、08907
        • Hospital Universitari de Bellvitge ( Site 6360)
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28007
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
      • Madrid、Madrid, Comunidad de、西班牙、28034
        • Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
  • 阿根廷
      • Buenos Aires、阿根廷、C1405CKC
        • Fundación IDEAA ( Site 5851)
      • Córdoba、阿根廷、X5000JJS
        • Instituto Oulton ( Site 5853)
    • Buenos Aires
      • CABA、Buenos Aires、阿根廷、C1427CEA
        • Fundación Huésped ( Site 5850)
      • Mar del Plata、Buenos Aires、阿根廷、B7600FZO
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、S2000PBJ
        • Instituto CAICI SRL ( Site 5852)
  • 马来西亚
      • Kuala Lumpur、马来西亚、50586
        • Hospital Kuala Lumpur ( Site 7773)
    • Kedah
      • Alor Star、Kedah、马来西亚、05460
        • Hospital Sultanah Bahiyah ( Site 7776)
    • Kuala Lumpur
      • Lembah Pantai、Kuala Lumpur、马来西亚、59100
        • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
    • Pulau Pinang
      • George Town、Pulau Pinang、马来西亚、10450
        • Hospital Pulau Pinang ( Site 7779)
    • Sarawak
      • Kuching、Sarawak、马来西亚、93586
        • Sarawak General Hospital ( Site 7772)
    • Selangor
      • Batu Caves、Selangor、马来西亚、68100
        • Hospital Selayang ( Site 7770)
      • Sungai Buloh、Selangor、马来西亚、47000
        • Hospital Sungai Buloh ( Site 7778)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：DOR/ISL

Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks.
药品：DOR/ISL

Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

其他名称：
  • MK-8591A
药品：Placebo to BIC/FTC/TAF

Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
有源比较器：BIC/FTC/TAF

Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.
药品：BIC/FTC/TAF

Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

药品：Placebo to DOR/ISL

Placebo tablet matched to DOR/ISL tablet taken by mouth.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月8日

初级完成 (实际的)

2025年10月13日

研究完成 (估计的)

2029年8月5日

研究注册日期

首次提交

2023年1月20日

首先提交符合 QC 标准的

2023年1月20日

首次发布 (实际的)

2023年1月30日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 8591A-053
  • 2022-502099-22-00 (注册表标识符：EU CT)
  • jRCT2031220720 (注册表标识符：jRCT)
  • U1111-1283-2516 (注册表标识符：UTN)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅