VK2735 for Weight Management Phase 3

NCT ID: NCT07104500

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo Assignment

VK2735 Placebo Comparator Once Weekly

Group Type PLACEBO_COMPARATOR

VK2735

Intervention Type DRUG

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Active Assignment (Dose 1)

VK2735 7.5mg Once Weekly

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Active Assignment (Dose 2)

VK2735 12.5mg Once Weekly

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Active Assignment (Dose 3)

VK2735 17.5mg Once Weekly

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Interventions

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VK2735

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viking Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Viking Clinical Site #1037

Birmingham, Alabama, United States

Site Status RECRUITING

Viking Clinical Site #1064

Birmingham, Alabama, United States

Site Status RECRUITING

Viking Clinical Site #1128

Huntsville, Alabama, United States

Site Status RECRUITING

Viking Clinical Site #1081

Mobile, Alabama, United States

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Viking Clinical Site #1005

Chandler, Arizona, United States

Site Status RECRUITING

Viking Clinical Site #1017

Flagstaff, Arizona, United States

Site Status RECRUITING

Viking Clinical Site #1018

Peoria, Arizona, United States

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Viking Clinical Site #1135

Scottsdale, Arizona, United States

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Viking Clinical Site #1019

Tucson, Arizona, United States

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Viking Clinical Site #1036

Little Rock, Arkansas, United States

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Viking Clinical Site #1071

Chula Vista, California, United States

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Viking Clinical Site #1070

Escondido, California, United States

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Viking Clinical Site #1054

Huntington Park, California, United States

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Viking Clinical Site #1014

Lake Forest, California, United States

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Viking Clinical Site #1129

Lemon Grove, California, United States

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Viking Clinical Site #1051

Lincoln, California, United States

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Viking Clinical Site #1050

Long Beach, California, United States

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Viking Clinical Site #1055

Los Angeles, California, United States

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Viking Clinical Site #1078

Manteca, California, United States

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Viking Clinical Site #1053

Montclair, California, United States

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Viking Clinical Site #1068

Panorama City, California, United States

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Viking Clinical Site #1132

Rolling Hills Estates, California, United States

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Viking Clinical Site #1131

San Diego, California, United States

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Viking Clinical Site #1104

Santa Maria, California, United States

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Viking Clinical Site #1052

Spring Valley, California, United States

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Viking Clinical Site #1109

Tustin, California, United States

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Viking Clinical Site #1067

Van Nuys, California, United States

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Viking Clinical Site #1079

Walnut Creek, California, United States

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Viking Clinical Site #1119

Denver, Colorado, United States

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Viking Clinical Site #1123

Washington D.C., District of Columbia, United States

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Viking Clinical Site #1013

Clearwater, Florida, United States

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Viking Clinical Site #1121

Clearwater, Florida, United States

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Viking Clinical Site #1003

Cooper City, Florida, United States

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Viking Clinical Site #1112

DeLand, Florida, United States

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Viking Clinical Site #1107

Delray Beach, Florida, United States

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Viking Clinical Site #1083

Fort Myers, Florida, United States

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Viking Clinical Site #1058

Jacksonville, Florida, United States

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Viking Clinical Site #1076

Lakeland, Florida, United States

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Viking Clinical Site #1060

Lakewood Rch, Florida, United States

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Viking Clinical Site #1117

Miami, Florida, United States

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Viking Clinical Site #1059

New Port Richey, Florida, United States

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Viking Clinical Site #1012

Ocoee, Florida, United States

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Viking Clinical Site #1056

Palmetto Bay, Florida, United States

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Viking Clinical Site #1011

Port Orange, Florida, United States

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Viking Clinical Site #1057

West Palm Beach, Florida, United States

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Viking Clinical Site #1116

Atlanta, Georgia, United States

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Viking Clinical Site #1030

Columbus, Georgia, United States

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Viking Clinical Site #1120

Rincon, Georgia, United States

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Viking Clinical Site #1093

Savannah, Georgia, United States

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Viking Clinical Site #1025

Woodstock, Georgia, United States

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Viking Clinical Site #1062

Honolulu, Hawaii, United States

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Viking Clinical Site #1080

Meridian, Idaho, United States

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Viking Clinical Site #1006

Chicago, Illinois, United States

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Viking Clinical Site #1090

Chicago, Illinois, United States

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Viking Clinical Site #1138

Westmont, Illinois, United States

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Viking Clinical Site #1127

Valparaiso, Indiana, United States

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Viking Clinical Site #1022

West Des Moines, Iowa, United States

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Viking Clinical Site #1099

Wichita, Kansas, United States

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Viking Clinical Site #1069

Lexington, Kentucky, United States

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Viking Clinical Site #1040

Lexington, Kentucky, United States

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Viking Clinical Site #1009

Louisville, Kentucky, United States

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Viking Clinical Site #1118

Baton Rouge, Louisiana, United States

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Viking Clinical Site #1139

Baton Rouge, Louisiana, United States

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Viking Clinical Site #1106

Lafayette, Louisiana, United States

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Viking Clinical Site #1020

Metairie, Louisiana, United States

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Viking Clinical Site #1087

Monroe, Louisiana, United States

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Viking Clinical Site #1094

Chevy Chase, Maryland, United States

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Viking Clinical Site #1066

Rockville, Maryland, United States

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Viking Clinical Site #1103

Boston, Massachusetts, United States

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Viking Clinical Site #1001

Methuen, Massachusetts, United States

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Viking Clinical Site #1136

Needham, Massachusetts, United States

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Viking Clinical Site #1038

Ypsilanti, Michigan, United States

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Viking Clinical Site #1140

Gulfport, Mississippi, United States

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Viking Clinical Site #1031

City of Saint Peters, Missouri, United States

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Viking Clinical Site #1016

Kansas City, Missouri, United States

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Viking Clinical Site #1125

Springfield, Missouri, United States

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Viking Clinical Site #1108

St Louis, Missouri, United States

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Viking Clinical Site #1010

Butte, Montana, United States

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Viking Clinical Site #1075

Omaha, Nebraska, United States

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Viking Clinical Site #1035

Las Vegas, Nevada, United States

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Viking Clinical Site #1034

Reno, Nevada, United States

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Viking Clinical Site #1065

Lebanon, New Hampshire, United States

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Viking Clinical Site #1095

Marlton, New Jersey, United States

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Viking Clinical Site #1029

Albuquerque, New Mexico, United States

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Viking Clinical Site #1088

Albany, New York, United States

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Viking Clinical Site #1042

East Syracuse, New York, United States

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Viking Clinical Site #1096

Hartsdale, New York, United States

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Viking Clinical Site #1133

New York, New York, United States

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Viking Clinical Site #1142

New York, New York, United States

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Viking Clinical Site #1021

The Bronx, New York, United States

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Viking Clinical Site #1032

Westfield, New York, United States

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Viking Clinical Site #1141

Charlotte, North Carolina, United States

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Viking Clinical Site #1122

Durham, North Carolina, United States

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Viking Clinical Site #1144

Fayetteville, North Carolina, United States

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Viking Clinical Site #1026

Greensboro, North Carolina, United States

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Viking Clinical Site #1110

Morehead City, North Carolina, United States

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Viking Clinical Site #1061

Morehead City, North Carolina, United States

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Viking Clinical Site #1027

Fargo, North Dakota, United States

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Viking Clinical Site #1043

Cincinnati, Ohio, United States

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Viking Clinical Site #1074

Cincinnati, Ohio, United States

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Viking Clinical Site #1044

Cleveland, Ohio, United States

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Viking Clinical Site #1089

Columbus, Ohio, United States

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Viking Clinical Site #1113

Norman, Oklahoma, United States

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Viking Clinical Site #1137

Tulsa, Oklahoma, United States

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Viking Clinical Site #1102

Medford, Oregon, United States

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Viking Clinical Site #1097

Portland, Oregon, United States

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Viking Clinical Site #1126

Portland, Oregon, United States

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Viking Clinical Site #1045

East Greenwich, Rhode Island, United States

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Viking Clinical Site #1028

Greenville, South Carolina, United States

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Viking Clinical Site #1134

Myrtle Beach, South Carolina, United States

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Viking Clinical Site #1023

North Charleston, South Carolina, United States

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Viking Clinical Site #1004

Knoxville, Tennessee, United States

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Viking Clinical Site #1008

Nashville, Tennessee, United States

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Viking Clinical Site #1047

Abilene, Texas, United States

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Viking Clinical Site #1063

Austin, Texas, United States

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Viking Clinical Site #1007

Austin, Texas, United States

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Viking Clinical Site #1091

Bellaire, Texas, United States

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Viking Clinical Site #1124

Brownsville, Texas, United States

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Viking Clinical Site #1049

Dallas, Texas, United States

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Viking Clinical Site #1048

Dallas, Texas, United States

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Viking Clinical Site #1111

Frisco, Texas, United States

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Viking Clinical Site #1046

Houston, Texas, United States

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Viking Clinical Site #1077

Lampasas, Texas, United States

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Viking Clinical Site #1143

San Antonio, Texas, United States

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Viking Clinical Site #1085

San Antonio, Texas, United States

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Viking Clinical Site #1073

San Antonio, Texas, United States

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Viking Clinical Site #1101

Waco, Texas, United States

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Viking Clinical Site #1002

Ogden, Utah, United States

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Viking Clinical Site #1092

Salt Lake City, Utah, United States

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Viking Clinical Site #1039

Sandy City, Utah, United States

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Viking Clinical Site #1024

St. George, Utah, United States

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Viking Clinical Site #1098

Arlington, Virginia, United States

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Viking Clinical Site #1082

Suffolk, Virginia, United States

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Viking Clinical Site #1072

Renton, Washington, United States

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Viking Clinical Site #1041

Spokane, Washington, United States

Site Status RECRUITING

Viking Clinical Site #1130

Mayagüez, , Puerto Rico

Site Status RECRUITING

Viking Clinical Site #1086

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

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United States Puerto Rico

Central Contacts

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Hannah Contreras

Role: CONTACT

Email: [email protected]

Facility Contacts

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Other Identifiers

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VK2735-301

Identifier Type: -

Identifier Source: org_study_id