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VK2735 for Weight Management Phase 3 (VANQUISH 1) III期 4,500 随机化 双盲 安慰剂对照

进行中（不再招募）
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临床试验NCT07104500 (VANQUISH 1)旨在研究治疗，主要针对体重减轻。这是一项III期 干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2025年6月23日，计划招募4,500名患者。该研究由Viking Therapeutics主导，预计于2027年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月24日。
简要概括
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
官方标题

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

疾病
体重减轻
其他研究标识符
  • VANQUISH 1
  • VK2735-301
NCT编号
NCT07104500
实际开始日期
2025-06-23
最近更新发布
2025-11-24
预计完成日期
2027-08-01
计划入组人数
4,500
研究类型
干预性研究
试验分期 (阶段)
III期
试验状态
进行中（不再招募）
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
安慰剂对照Placebo Assignment
VK2735 Placebo Comparator Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
实验性Active Assignment (Dose 1)
VK2735 7.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
实验性Active Assignment (Dose 2)
VK2735 12.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
实验性Active Assignment (Dose 3)
VK2735 17.5mg Once Weekly
VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
主要终点
结果指标度量标准描述时间框架
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
78 Weeks
次要终点
结果指标度量标准描述时间框架
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment
78 Weeks
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部

  1. Age ≥18 years of age at the time of signing the informed consent

  2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)

    • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
    • Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
    • BMI calculated at the Screening visit will be used to determine eligibility

  1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  2. Self-reported body weight change of 5% or more within 3 months of screening
  3. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
  4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
  5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
  6. Treatment with glucose-lowering agent(s) within 90 days before screening
  7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  8. History of acute or chronic pancreatitis
Viking Therapeutics, Inc. logoViking Therapeutics
没有联系数据。
137 位于 2 个国家/地区的研究中心

Alabama

Viking Clinical Site #1037, Birmingham, Alabama, 35235, United States
Viking Clinical Site #1064, Birmingham, Alabama, 35249, United States
Viking Clinical Site #1128, Huntsville, Alabama, 35801, United States
Viking Clinical Site #1081, Mobile, Alabama, 36608, United States

Arizona

Viking Clinical Site #1005, Chandler, Arizona, 85210, United States
Viking Clinical Site #1017, Flagstaff, Arizona, 86001, United States
Viking Clinical Site #1018, Peoria, Arizona, 85381, United States
Viking Clinical Site #1135, Scottsdale, Arizona, 85260, United States
Viking Clinical Site #1019, Tucson, Arizona, 85711, United States

Arkansas

Viking Clinical Site #1036, Little Rock, Arkansas, 72211, United States

California

Viking Clinical Site #1071, Chula Vista, California, 91911, United States
Viking Clinical Site #1070, Escondido, California, 92025, United States
Viking Clinical Site #1054, Huntington Park, California, 90255, United States
Viking Clinical Site #1014, Lake Forest, California, 92630, United States
Viking Clinical Site #1129, Lemon Grove, California, 91945, United States
Viking Clinical Site #1051, Lincoln, California, 95648, United States
Viking Clinical Site #1050, Long Beach, California, 90815, United States
Viking Clinical Site #1055, Los Angeles, California, 90057, United States
Viking Clinical Site #1078, Manteca, California, 95336, United States
Viking Clinical Site #1053, Montclair, California, 91763, United States
Viking Clinical Site #1068, Panorama City, California, 91402, United States
Viking Clinical Site #1132, Rolling Hills Estates, California, 90274, United States
Viking Clinical Site #1131, San Diego, California, 92103, United States
Viking Clinical Site #1104, Santa Maria, California, 93458, United States
Viking Clinical Site #1052, Spring Valley, California, 91978, United States
Viking Clinical Site #1109, Tustin, California, 92780, United States
Viking Clinical Site #1067, Van Nuys, California, 91405, United States
Viking Clinical Site #1079, Walnut Creek, California, 94598, United States

Colorado

Viking Clinical Site #1119, Denver, Colorado, 80210, United States

District of Columbia

Viking Clinical Site #1123, Washington D.C., District of Columbia, 20036, United States

Florida

Viking Clinical Site #1013, Clearwater, Florida, 33756, United States
Viking Clinical Site #1121, Clearwater, Florida, 33761, United States
Viking Clinical Site #1003, Cooper City, Florida, 33024, United States
Viking Clinical Site #1112, DeLand, Florida, 32720, United States
Viking Clinical Site #1107, Delray Beach, Florida, 33445, United States
Viking Clinical Site #1083, Fort Myers, Florida, 33912, United States
Viking Clinical Site #1058, Jacksonville, Florida, 32216, United States
Viking Clinical Site #1076, Lakeland, Florida, 33803, United States
Viking Clinical Site #1060, Lakewood Rch, Florida, 34211, United States
Viking Clinical Site #1117, Miami, Florida, 33122, United States
Viking Clinical Site #1059, New Port Richey, Florida, 34652, United States
Viking Clinical Site #1012, Ocoee, Florida, 34761, United States
Viking Clinical Site #1056, Palmetto Bay, Florida, 33157, United States
Viking Clinical Site #1011, Port Orange, Florida, 32127, United States
Viking Clinical Site #1057, West Palm Beach, Florida, 33407, United States

Georgia

Viking Clinical Site #1116, Atlanta, Georgia, 30329, United States
Viking Clinical Site #1030, Columbus, Georgia, 31904, United States
Viking Clinical Site #1120, Rincon, Georgia, 31326, United States
Viking Clinical Site #1093, Savannah, Georgia, 31406, United States
Viking Clinical Site #1025, Woodstock, Georgia, 30189, United States

Hawaii

Viking Clinical Site #1062, Honolulu, Hawaii, 96814, United States

Idaho

Viking Clinical Site #1080, Meridian, Idaho, 83642, United States

Illinois

Viking Clinical Site #1006, Chicago, Illinois, 60607, United States
Viking Clinical Site #1090, Chicago, Illinois, 60640, United States
Viking Clinical Site #1138, Westmont, Illinois, 60559, United States

Indiana

Viking Clinical Site #1127, Valparaiso, Indiana, 46383, United States

Iowa

Viking Clinical Site #1022, West Des Moines, Iowa, 50266, United States

Kansas

Viking Clinical Site #1099, Wichita, Kansas, 67207, United States

Kentucky

Viking Clinical Site #1069, Lexington, Kentucky, 40509, United States
Viking Clinical Site #1040, Lexington, Kentucky, 40513, United States
Viking Clinical Site #1009, Louisville, Kentucky, 40213, United States

Louisiana

Viking Clinical Site #1118, Baton Rouge, Louisiana, 70808, United States
Viking Clinical Site #1139, Baton Rouge, Louisiana, 70809, United States
Viking Clinical Site #1106, Lafayette, Louisiana, 70508, United States
Viking Clinical Site #1020, Metairie, Louisiana, 70006, United States
Viking Clinical Site #1087, Monroe, Louisiana, 71201, United States

Maryland

Viking Clinical Site #1094, Chevy Chase, Maryland, 20815, United States
Viking Clinical Site #1066, Rockville, Maryland, 20854, United States

Massachusetts

Viking Clinical Site #1103, Boston, Massachusetts, 02114, United States
Viking Clinical Site #1001, Methuen, Massachusetts, 01844, United States
Viking Clinical Site #1136, Needham, Massachusetts, 02492, United States

Michigan

Viking Clinical Site #1038, Ypsilanti, Michigan, 48197, United States

Mississippi

Viking Clinical Site #1140, Gulfport, Mississippi, 39503, United States

Missouri

Viking Clinical Site #1031, City of Saint Peters, Missouri, 63303, United States
Viking Clinical Site #1016, Kansas City, Missouri, 64131, United States
Viking Clinical Site #1125, Springfield, Missouri, 65807, United States
Viking Clinical Site #1108, St Louis, Missouri, 63108, United States

Montana

Viking Clinical Site #1010, Butte, Montana, 59701, United States

Nebraska

Viking Clinical Site #1075, Omaha, Nebraska, 68134, United States

Nevada

Viking Clinical Site #1035, Las Vegas, Nevada, 89148, United States
Viking Clinical Site #1034, Reno, Nevada, 89511, United States

New Hampshire

Viking Clinical Site #1065, Lebanon, New Hampshire, 03756, United States

New Jersey

Viking Clinical Site #1095, Marlton, New Jersey, 08009, United States

New Mexico

Viking Clinical Site #1029, Albuquerque, New Mexico, 87109, United States

New York

Viking Clinical Site #1088, Albany, New York, 12205, United States
Viking Clinical Site #1042, East Syracuse, New York, 13057, United States
Viking Clinical Site #1096, Hartsdale, New York, 10530, United States
Viking Clinical Site #1133, New York, New York, 10036, United States
Viking Clinical Site #1142, New York, New York, 10065, United States
Viking Clinical Site #1021, The Bronx, New York, 10455, United States
Viking Clinical Site #1032, Westfield, New York, 14787, United States

North Carolina

Viking Clinical Site #1141, Charlotte, North Carolina, 28250, United States
Viking Clinical Site #1122, Durham, North Carolina, 27701, United States
Viking Clinical Site #1144, Fayetteville, North Carolina, 28304, United States
Viking Clinical Site #1026, Greensboro, North Carolina, 27410, United States
Viking Clinical Site #1110, Morehead City, North Carolina, 28557, United States
Viking Clinical Site #1061, Morehead City, North Carolina, 28857, United States

North Dakota

Viking Clinical Site #1027, Fargo, North Dakota, 58104, United States

Ohio

Viking Clinical Site #1043, Cincinnati, Ohio, 45219, United States
Viking Clinical Site #1074, Cincinnati, Ohio, 45242, United States
Viking Clinical Site #1044, Cleveland, Ohio, 44122, United States
Viking Clinical Site #1089, Columbus, Ohio, 43215, United States

Oklahoma

Viking Clinical Site #1113, Norman, Oklahoma, 73069, United States
Viking Clinical Site #1137, Tulsa, Oklahoma, 74133, United States

Oregon

Viking Clinical Site #1102, Medford, Oregon, 97504, United States
Viking Clinical Site #1097, Portland, Oregon, 97202, United States
Viking Clinical Site #1126, Portland, Oregon, 97210, United States

Rhode Island

Viking Clinical Site #1045, East Greenwich, Rhode Island, 02818, United States

South Carolina

Viking Clinical Site #1028, Greenville, South Carolina, 29607, United States
Viking Clinical Site #1134, Myrtle Beach, South Carolina, 29572, United States
Viking Clinical Site #1023, North Charleston, South Carolina, 29405, United States

Tennessee

Viking Clinical Site #1004, Knoxville, Tennessee, 37909, United States
Viking Clinical Site #1008, Nashville, Tennessee, 37203, United States

Texas

Viking Clinical Site #1047, Abilene, Texas, 79606, United States
Viking Clinical Site #1063, Austin, Texas, 78131, United States
Viking Clinical Site #1007, Austin, Texas, 78705, United States
Viking Clinical Site #1091, Bellaire, Texas, 77401, United States
Viking Clinical Site #1124, Brownsville, Texas, 78526, United States
Viking Clinical Site #1049, Dallas, Texas, 75230, United States
Viking Clinical Site #1048, Dallas, Texas, 75235, United States
Viking Clinical Site #1111, Frisco, Texas, 75033, United States
Viking Clinical Site #1046, Houston, Texas, 77040, United States
Viking Clinical Site #1077, Lampasas, Texas, 76550, United States
Viking Clinical Site #1143, San Antonio, Texas, 78215, United States
Viking Clinical Site #1085, San Antonio, Texas, 78222, United States
Viking Clinical Site #1073, San Antonio, Texas, 78229, United States
Viking Clinical Site #1101, Waco, Texas, 76710, United States

Utah

Viking Clinical Site #1002, Ogden, Utah, 84405, United States
Viking Clinical Site #1092, Salt Lake City, Utah, 84107, United States
Viking Clinical Site #1039, Sandy City, Utah, 84094, United States
Viking Clinical Site #1024, St. George, Utah, 84790, United States

Virginia

Viking Clinical Site #1098, Arlington, Virginia, 22205, United States
Viking Clinical Site #1082, Suffolk, Virginia, 23435, United States

Washington

Viking Clinical Site #1072, Renton, Washington, 98057, United States
Viking Clinical Site #1041, Spokane, Washington, 99218, United States
Viking Clinical Site #1130, Mayagüez, 00680, Puerto Rico
Viking Clinical Site #1086, San Juan, 00927, Puerto Rico