RECRUITING

VK2735 for Weight Management Phase 3

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Conditions

Weight Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-23
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07104500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years of age at the time of signing the informed consent
  2. 2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)
  3. * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
  4. * Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
  5. * BMI calculated at the Screening visit will be used to determine eligibility
  1. 1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  2. 2. Self-reported body weight change of 5% or more within 3 months of screening
  3. 3. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
  4. 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. 5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
  6. 6. Treatment with glucose-lowering agent(s) within 90 days before screening
  7. 7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  8. 8. History of acute or chronic pancreatitis

Contacts and Locations

Study Contact

Hannah Contreras
CONTACT
Clinicaltrials@vikingtherapeutics.com

Study Locations (Sites)

Viking Clinical Site #1037
Birmingham, Alabama, 35235
United States
Viking Clinical Site #1128
Huntsville, Alabama, 35801
United States
Viking Clinical Site #1081
Mobile, Alabama, 36608
United States
Viking Clinical Site #1005
Chandler, Arizona, 85210
United States
Viking Clinical Site #1017
Flagstaff, Arizona, 86001
United States
Viking Clinical Site #1135
Scottsdale, Arizona, 85260
United States
Viking Clinical Site #1019
Tucson, Arizona, 85711
United States
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 #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 #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
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 #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
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
Viking Clinical Site #1062
Honolulu, Hawaii, 96814
United States
Viking Clinical Site #1080
Meridian, Idaho, 83642
United States
Viking Clinical Site #1006
Chicago, Illinois, 60607
United States
Viking Clinical Site #1090
Chicago, Illinois, 60640
United States
Viking Clinical Site #1127
Valparaiso, Indiana, 46383
United States
Viking Clinical Site #1022
West Des Moines, Iowa, 50266
United States
Viking Clinical Site #1099
Wichita, Kansas, 67207
United States
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
Viking Clinical Site #1139
Baton Rouge, Louisiana, 70809
United States
Viking Clinical Site #1020
Metairie, Louisiana, 70006
United States
Viking Clinical Site #1094
Chevy Chase, Maryland, 20815
United States
Viking Clinical Site #1066
Rockville, Maryland, 20854
United States
Viking Clinical Site #1001
Methuen, Massachusetts, 01844
United States
Viking Clinical Site #1038
Ypsilanti, Michigan, 48197
United States
Viking Clinical Site #1140
Gulfport, Mississippi, 39503
United States
Viking Clinical Site #1016
Kansas City, Missouri, 64131
United States
Viking Clinical Site #1031
Saint Peters, Missouri, 63303
United States
Viking Clinical Site #1125
Springfield, Missouri, 65807
United States
Viking Clinical Site #1010
Butte, Montana, 59701
United States
Viking Clinical Site #1075
Omaha, Nebraska, 68134
United States
Viking Clinical Site #1035
Las Vegas, Nevada, 89148
United States
Viking Clinical Site #1029
Albuquerque, New Mexico, 87109
United States
Viking Clinical Site #1088
Albany, New York, 12205
United States
Viking Clinical Site #1021
Bronx, New York, 10455
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 #1032
Westfield, New York, 14787
United States
Viking Clinical Site #1141
Charlotte, North Carolina, 28250
United States
Viking Clinical Site #1122
Durham, North Carolina, 27701
United States
Viking Clinical Site #1026
Greensboro, North Carolina, 27410
United States
Viking Clinical Site #1061
Morehead City, North Carolina, 28857
United States
Viking Clinical Site #1027
Fargo, North Dakota, 58104
United States
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
Viking Clinical Site #1113
Norman, Oklahoma, 73069
United States
Viking Clinical Site #1137
Tulsa, Oklahoma, 74133
United States
Viking Clinical Site #1102
Medford, Oregon, 97504
United States
Viking Clinical Site #1126
Portland, Oregon, 97210
United States
Viking Clinical Site #1045
East Greenwich, Rhode Island, 02818
United States
Viking Clinical Site #1134
Myrtle Beach, South Carolina, 29572
United States
Viking Clinical Site #1023
North Charleston, South Carolina, 29405
United States
Viking Clinical Site #1004
Knoxville, Tennessee, 37909
United States
Viking Clinical Site #1008
Nashville, Tennessee, 37203
United States
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 #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 #1046
Houston, Texas, 77040
United States
Viking Clinical Site #1077
Lampasas, Texas, 76550
United States
Viking Clinical Site #1073
San Antonio, Texas, 78229
United States
Viking Clinical Site #1101
Waco, Texas, 76710
United States
Viking Clinical Site #1002
Ogden, Utah, 84405
United States
Viking Clinical Site #1024
Saint George, Utah, 84790
United States
Viking Clinical Site #1092
Salt Lake City, Utah, 84107
United States
Viking Clinical Site #1082
Suffolk, Virginia, 23435
United States
Viking Clinical Site #1072
Renton, Washington, 98057
United States
Viking Clinical Site #1041
Spokane, Washington, 99218
United States

Collaborators and Investigators

Sponsor: Viking Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2027-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Weight Loss