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
Status: Recruiting
Location: See all (136) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years of age at the time of signing the informed consent
• 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
Locations
United States
Alabama
Viking Clinical Site #1037
RECRUITING
Birmingham
Viking Clinical Site #1064
RECRUITING
Birmingham
Viking Clinical Site #1128
RECRUITING
Huntsville
Viking Clinical Site #1081
RECRUITING
Mobile
Arkansas
Viking Clinical Site #1036
RECRUITING
Little Rock
Arizona
Viking Clinical Site #1005
RECRUITING
Chandler
Viking Clinical Site #1017
RECRUITING
Flagstaff
Viking Clinical Site #1018
RECRUITING
Peoria
Viking Clinical Site #1135
RECRUITING
Scottsdale
Viking Clinical Site #1019
RECRUITING
Tucson
California
Viking Clinical Site #1071
RECRUITING
Chula Vista
Viking Clinical Site #1070
RECRUITING
Escondido
Viking Clinical Site #1054
RECRUITING
Huntington Park
Viking Clinical Site #1014
RECRUITING
Lake Forest
Viking Clinical Site #1129
RECRUITING
Lemon Grove
Viking Clinical Site #1051
RECRUITING
Lincoln
Viking Clinical Site #1050
RECRUITING
Long Beach
Viking Clinical Site #1055
RECRUITING
Los Angeles
Viking Clinical Site #1078
RECRUITING
Manteca
Viking Clinical Site #1053
RECRUITING
Montclair
Viking Clinical Site #1068
RECRUITING
Panorama City
Viking Clinical Site #1132
RECRUITING
Rolling Hills Estates
Viking Clinical Site #1131
RECRUITING
San Diego
Viking Clinical Site #1104
RECRUITING
Santa Maria
Viking Clinical Site #1052
RECRUITING
Spring Valley
Viking Clinical Site #1109
RECRUITING
Tustin
Viking Clinical Site #1067
RECRUITING
Van Nuys
Viking Clinical Site #1079
RECRUITING
Walnut Creek
Colorado
Viking Clinical Site #1119
RECRUITING
Denver
Washington, D.c.
Viking Clinical Site #1123
RECRUITING
Washington D.c.
Florida
Viking Clinical Site #1013
RECRUITING
Clearwater
Viking Clinical Site #1121
RECRUITING
Clearwater
Viking Clinical Site #1003
RECRUITING
Cooper City
Viking Clinical Site #1112
RECRUITING
Deland
Viking Clinical Site #1107
RECRUITING
Delray Beach
Viking Clinical Site #1083
RECRUITING
Fort Myers
Viking Clinical Site #1058
RECRUITING
Jacksonville
Viking Clinical Site #1076
RECRUITING
Lakeland
Viking Clinical Site #1060
RECRUITING
Lakewood Rch
Viking Clinical Site #1117
ACTIVE_NOT_RECRUITING
Miami
Viking Clinical Site #1059
RECRUITING
New Port Richey
Viking Clinical Site #1012
RECRUITING
Ocoee
Viking Clinical Site #1056
RECRUITING
Palmetto Bay
Viking Clinical Site #1011
RECRUITING
Port Orange
Viking Clinical Site #1057
RECRUITING
West Palm Beach
Georgia
Viking Clinical Site #1116
RECRUITING
Atlanta
Viking Clinical Site #1030
RECRUITING
Columbus
Viking Clinical Site #1120
RECRUITING
Rincon
Viking Clinical Site #1093
RECRUITING
Savannah
Viking Clinical Site #1025
RECRUITING
Woodstock
Hawaii
Viking Clinical Site #1062
RECRUITING
Honolulu
Iowa
Viking Clinical Site #1022
RECRUITING
West Des Moines
Idaho
Viking Clinical Site #1080
RECRUITING
Meridian
Illinois
Viking Clinical Site #1006
RECRUITING
Chicago
Viking Clinical Site #1090
RECRUITING
Chicago
Viking Clinical Site #1138
RECRUITING
Westmont
Indiana
Viking Clinical Site #1127
RECRUITING
Valparaiso
Kansas
Viking Clinical Site #1099
RECRUITING
Wichita
Kentucky
Viking Clinical Site #1040
RECRUITING
Lexington
Viking Clinical Site #1069
RECRUITING
Lexington
Viking Clinical Site #1009
RECRUITING
Louisville
Louisiana
Viking Clinical Site #1118
ACTIVE_NOT_RECRUITING
Baton Rouge
Viking Clinical Site #1139
RECRUITING
Baton Rouge
Viking Clinical Site #1106
RECRUITING
Lafayette
Viking Clinical Site #1020
RECRUITING
Metairie
Viking Clinical Site #1087
RECRUITING
Monroe
Massachusetts
Viking Clinical Site #1103
RECRUITING
Boston
Viking Clinical Site #1001
RECRUITING
Methuen
Viking Clinical Site #1136
RECRUITING
Needham
Maryland
Viking Clinical Site #1094
RECRUITING
Chevy Chase
Viking Clinical Site #1066
RECRUITING
Rockville
Michigan
Viking Clinical Site #1038
RECRUITING
Ypsilanti
Missouri
Viking Clinical Site #1031
RECRUITING
City Of Saint Peters
Viking Clinical Site #1016
RECRUITING
Kansas City
Viking Clinical Site #1125
RECRUITING
Springfield
Viking Clinical Site #1108
RECRUITING
St Louis
Mississippi
Viking Clinical Site #1140
RECRUITING
Gulfport
Montana
Viking Clinical Site #1010
RECRUITING
Butte
North Carolina
Viking Clinical Site #1141
RECRUITING
Charlotte
Viking Clinical Site #1122
RECRUITING
Durham
Viking Clinical Site #1144
RECRUITING
Fayetteville
Viking Clinical Site #1026
RECRUITING
Greensboro
Viking Clinical Site #1061
RECRUITING
Morehead City
Viking Clinical Site #1110
RECRUITING
Morehead City
North Dakota
Viking Clinical Site #1027
RECRUITING
Fargo
Nebraska
Viking Clinical Site #1075
RECRUITING
Omaha
New Jersey
Viking Clinical Site #1095
RECRUITING
Marlton
New Mexico
Viking Clinical Site #1029
RECRUITING
Albuquerque
Nevada
Viking Clinical Site #1035
RECRUITING
Las Vegas
Viking Clinical Site #1034
RECRUITING
Reno
New York
Viking Clinical Site #1088
RECRUITING
Albany
Viking Clinical Site #1042
RECRUITING
East Syracuse
Viking Clinical Site #1096
RECRUITING
Hartsdale
Viking Clinical Site #1133
RECRUITING
New York
Viking Clinical Site #1142
RECRUITING
New York
Viking Clinical Site #1021
RECRUITING
The Bronx
Viking Clinical Site #1032
RECRUITING
Westfield
Ohio
Viking Clinical Site #1043
RECRUITING
Cincinnati
Viking Clinical Site #1074
RECRUITING
Cincinnati
Viking Clinical Site #1044
RECRUITING
Cleveland
Viking Clinical Site #1089
RECRUITING
Columbus
Oklahoma
Viking Clinical Site #1113
RECRUITING
Norman
Viking Clinical Site #1137
RECRUITING
Tulsa
Oregon
Viking Clinical Site #1102
RECRUITING
Medford
Viking Clinical Site #1097
RECRUITING
Portland
Viking Clinical Site #1126
RECRUITING
Portland
Rhode Island
Viking Clinical Site #1045
RECRUITING
East Greenwich
South Carolina
Viking Clinical Site #1028
RECRUITING
Greenville
Viking Clinical Site #1134
RECRUITING
Myrtle Beach
Viking Clinical Site #1023
RECRUITING
North Charleston
Tennessee
Viking Clinical Site #1004
RECRUITING
Knoxville
Viking Clinical Site #1008
RECRUITING
Nashville
Texas
Viking Clinical Site #1047
RECRUITING
Abilene
Viking Clinical Site #1007
RECRUITING
Austin
Viking Clinical Site #1063
RECRUITING
Austin
Viking Clinical Site #1091
RECRUITING
Bellaire
Viking Clinical Site #1124
RECRUITING
Brownsville
Viking Clinical Site #1048
RECRUITING
Dallas
Viking Clinical Site #1049
RECRUITING
Dallas
Viking Clinical Site #1111
RECRUITING
Frisco
Viking Clinical Site #1046
RECRUITING
Houston
Viking Clinical Site #1077
RECRUITING
Lampasas
Viking Clinical Site #1073
RECRUITING
San Antonio
Viking Clinical Site #1085
RECRUITING
San Antonio
Viking Clinical Site #1143
RECRUITING
San Antonio
Viking Clinical Site #1101
RECRUITING
Waco
Utah
Viking Clinical Site #1002
RECRUITING
Ogden
Viking Clinical Site #1092
RECRUITING
Salt Lake City
Viking Clinical Site #1039
RECRUITING
Sandy City
Viking Clinical Site #1024
RECRUITING
St. George
Virginia
Viking Clinical Site #1098
RECRUITING
Arlington
Viking Clinical Site #1082
RECRUITING
Suffolk
Washington
Viking Clinical Site #1072
RECRUITING
Renton
Viking Clinical Site #1041
RECRUITING
Spokane
Other Locations
Puerto Rico
Viking Clinical Site #1130
RECRUITING
Mayagüez
Viking Clinical Site #1086
RECRUITING
San Juan
Contact Information
Primary
Hannah Contreras
Clinicaltrials@vikingtherapeutics.com
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 4500
Treatments
Placebo_comparator: Placebo Assignment
VK2735 Placebo Comparator Once Weekly
Experimental: Active Assignment (Dose 1)
VK2735 7.5mg Once Weekly
Experimental: Active Assignment (Dose 2)
VK2735 12.5mg Once Weekly
Experimental: Active Assignment (Dose 3)
VK2735 17.5mg Once Weekly
Related Therapeutic Areas
Sponsors
Leads: Viking Therapeutics, Inc.