VK2735 for Weight Management Phase 3

NCT07104500 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VK2735-301
• Study Type: interventional
• Target: 4,500
• Locations: 2 countries
• Sites: 137

Brief 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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment

  78 Weeks

Secondary Outcomes (1)

• Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment

  78 Weeks

Study Arms (4)

Placebo Assignment

PLACEBO COMPARATOR

VK2735 Placebo Comparator Once Weekly

Drug: VK2735

Active Assignment (Dose 1)

EXPERIMENTAL

VK2735 7.5mg Once Weekly

Drug: VK2735

Active Assignment (Dose 2)

EXPERIMENTAL

VK2735 12.5mg Once Weekly

Drug: VK2735

Active Assignment (Dose 3)

EXPERIMENTAL

VK2735 17.5mg Once Weekly

Drug: VK2735

Interventions

VK2735 DRUG

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

Active Assignment (Dose 1); Active Assignment (Dose 2); Active Assignment (Dose 3); Placebo Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
• Self-reported body weight change of 5% or more within 3 months of screening
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
• 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)
• Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
• Treatment with glucose-lowering agent(s) within 90 days before screening
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• History of acute or chronic pancreatitis

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (137)

Viking Clinical Site #1037

Birmingham, Alabama, 35235, United States

Location

Viking Clinical Site #1064

Birmingham, Alabama, 35249, United States

Location

Viking Clinical Site #1128

Huntsville, Alabama, 35801, United States

Location

Viking Clinical Site #1081

Mobile, Alabama, 36608, United States

Location

Viking Clinical Site #1005

Chandler, Arizona, 85210, United States

Location

Viking Clinical Site #1017

Flagstaff, Arizona, 86001, United States

Location

Viking Clinical Site #1018

Peoria, Arizona, 85381, United States

Location

Viking Clinical Site #1135

Scottsdale, Arizona, 85260, United States

Location

Viking Clinical Site #1019

Tucson, Arizona, 85711, United States

Location

Viking Clinical Site #1036

Little Rock, Arkansas, 72211, United States

Location

Viking Clinical Site #1071

Chula Vista, California, 91911, United States

Location

Viking Clinical Site #1070

Escondido, California, 92025, United States

Location

Viking Clinical Site #1054

Huntington Park, California, 90255, United States

Location

Viking Clinical Site #1014

Lake Forest, California, 92630, United States

Location

Viking Clinical Site #1129

Lemon Grove, California, 91945, United States

Location

Viking Clinical Site #1051

Lincoln, California, 95648, United States

Location

Viking Clinical Site #1050

Long Beach, California, 90815, United States

Location

Viking Clinical Site #1055

Los Angeles, California, 90057, United States

Location

Viking Clinical Site #1078

Manteca, California, 95336, United States

Location

Viking Clinical Site #1053

Montclair, California, 91763, United States

Location

Viking Clinical Site #1068

Panorama City, California, 91402, United States

Location

Viking Clinical Site #1132

Rolling Hills Estates, California, 90274, United States

Location

Viking Clinical Site #1131

San Diego, California, 92103, United States

Location

Viking Clinical Site #1104

Santa Maria, California, 93458, United States

Location

Viking Clinical Site #1052

Spring Valley, California, 91978, United States

Location

Viking Clinical Site #1109

Tustin, California, 92780, United States

Location

Viking Clinical Site #1067

Van Nuys, California, 91405, United States

Location

Viking Clinical Site #1079

Walnut Creek, California, 94598, United States

Location

Viking Clinical Site #1119

Denver, Colorado, 80210, United States

Location

Viking Clinical Site #1123

Washington D.C., District of Columbia, 20036, United States

Location

Viking Clinical Site #1013

Clearwater, Florida, 33756, United States

Location

Viking Clinical Site #1121

Clearwater, Florida, 33761, United States

Location

Viking Clinical Site #1003

Cooper City, Florida, 33024, United States

Location

Viking Clinical Site #1112

DeLand, Florida, 32720, United States

Location

Viking Clinical Site #1107

Delray Beach, Florida, 33445, United States

Location

Viking Clinical Site #1083

Fort Myers, Florida, 33912, United States

Location

Viking Clinical Site #1058

Jacksonville, Florida, 32216, United States

Location

Viking Clinical Site #1076

Lakeland, Florida, 33803, United States

Location

Viking Clinical Site #1060

Lakewood Rch, Florida, 34211, United States

Location

Viking Clinical Site #1117

Miami, Florida, 33122, United States

Location

Viking Clinical Site #1059

New Port Richey, Florida, 34652, United States

Location

Viking Clinical Site #1012

Ocoee, Florida, 34761, United States

Location

Viking Clinical Site #1056

Palmetto Bay, Florida, 33157, United States

Location

Viking Clinical Site #1011

Port Orange, Florida, 32127, United States

Location

Viking Clinical Site #1057

West Palm Beach, Florida, 33407, United States

Location

Viking Clinical Site #1116

Atlanta, Georgia, 30329, United States

Location

Viking Clinical Site #1030

Columbus, Georgia, 31904, United States

Location

Viking Clinical Site #1120

Rincon, Georgia, 31326, United States

Location

Viking Clinical Site #1093

Savannah, Georgia, 31406, United States

Location

Viking Clinical Site #1025

Woodstock, Georgia, 30189, United States

Location

Viking Clinical Site #1062

Honolulu, Hawaii, 96814, United States

Location

Viking Clinical Site #1080

Meridian, Idaho, 83642, United States

Location

Viking Clinical Site #1006

Chicago, Illinois, 60607, United States

Location

Viking Clinical Site #1090

Chicago, Illinois, 60640, United States

Location

Viking Clinical Site #1138

Westmont, Illinois, 60559, United States

Location

Viking Clinical Site #1127

Valparaiso, Indiana, 46383, United States

Location

Viking Clinical Site #1022

West Des Moines, Iowa, 50266, United States

Location

Viking Clinical Site #1099

Wichita, Kansas, 67207, United States

Location

Viking Clinical Site #1069

Lexington, Kentucky, 40509, United States

Location

Viking Clinical Site #1040

Lexington, Kentucky, 40513, United States

Location

Viking Clinical Site #1009

Louisville, Kentucky, 40213, United States

Location

Viking Clinical Site #1118

Baton Rouge, Louisiana, 70808, United States

Location

Viking Clinical Site #1139

Baton Rouge, Louisiana, 70809, United States

Location

Viking Clinical Site #1106

Lafayette, Louisiana, 70508, United States

Location

Viking Clinical Site #1020

Metairie, Louisiana, 70006, United States

Location

Viking Clinical Site #1087

Monroe, Louisiana, 71201, United States

Location

Viking Clinical Site #1094

Chevy Chase, Maryland, 20815, United States

Location

Viking Clinical Site #1066

Rockville, Maryland, 20854, United States

Location

Viking Clinical Site #1103

Boston, Massachusetts, 02114, United States

Location

Viking Clinical Site #1001

Methuen, Massachusetts, 01844, United States

Location

Viking Clinical Site #1136

Needham, Massachusetts, 02492, United States

Location

Viking Clinical Site #1038

Ypsilanti, Michigan, 48197, United States

Location

Viking Clinical Site #1140

Gulfport, Mississippi, 39503, United States

Location

Viking Clinical Site #1031

City of Saint Peters, Missouri, 63303, United States

Location

Viking Clinical Site #1016

Kansas City, Missouri, 64131, United States

Location

Viking Clinical Site #1125

Springfield, Missouri, 65807, United States

Location

Viking Clinical Site #1108

St Louis, Missouri, 63108, United States

Location

Viking Clinical Site #1010

Butte, Montana, 59701, United States

Location

Viking Clinical Site #1075

Omaha, Nebraska, 68134, United States

Location

Viking Clinical Site #1035

Las Vegas, Nevada, 89148, United States

Location

Viking Clinical Site #1034

Reno, Nevada, 89511, United States

Location

Viking Clinical Site #1065

Lebanon, New Hampshire, 03756, United States

Location

Viking Clinical Site #1095

Marlton, New Jersey, 08009, United States

Location

Viking Clinical Site #1029

Albuquerque, New Mexico, 87109, United States

Location

Viking Clinical Site #1088

Albany, New York, 12205, United States

Location

Viking Clinical Site #1042

East Syracuse, New York, 13057, United States

Location

Viking Clinical Site #1096

Hartsdale, New York, 10530, United States

Location

Viking Clinical Site #1133

New York, New York, 10036, United States

Location

Viking Clinical Site #1142

New York, New York, 10065, United States

Location

Viking Clinical Site #1021

The Bronx, New York, 10455, United States

Location

Viking Clinical Site #1032

Westfield, New York, 14787, United States

Location

Viking Clinical Site #1141

Charlotte, North Carolina, 28250, United States

Location

Viking Clinical Site #1122

Durham, North Carolina, 27701, United States

Location

Viking Clinical Site #1144

Fayetteville, North Carolina, 28304, United States

Location

Viking Clinical Site #1026

Greensboro, North Carolina, 27410, United States

Location

Viking Clinical Site #1110

Morehead City, North Carolina, 28557, United States

Location

Viking Clinical Site #1061

Morehead City, North Carolina, 28857, United States

Location

Viking Clinical Site #1027

Fargo, North Dakota, 58104, United States

Location

Viking Clinical Site #1043

Cincinnati, Ohio, 45219, United States

Location

Viking Clinical Site #1074

Cincinnati, Ohio, 45242, United States

Location

Viking Clinical Site #1044

Cleveland, Ohio, 44122, United States

Location

Viking Clinical Site #1089

Columbus, Ohio, 43215, United States

Location

Viking Clinical Site #1113

Norman, Oklahoma, 73069, United States

Location

Viking Clinical Site #1137

Tulsa, Oklahoma, 74133, United States

Location

Viking Clinical Site #1102

Medford, Oregon, 97504, United States

Location

Viking Clinical Site #1097

Portland, Oregon, 97202, United States

Location

Viking Clinical Site #1126

Portland, Oregon, 97210, United States

Location

Viking Clinical Site #1045

East Greenwich, Rhode Island, 02818, United States

Location

Viking Clinical Site #1028

Greenville, South Carolina, 29607, United States

Location

Viking Clinical Site #1134

Myrtle Beach, South Carolina, 29572, United States

Location

Viking Clinical Site #1023

North Charleston, South Carolina, 29405, United States

Location

Viking Clinical Site #1004

Knoxville, Tennessee, 37909, United States

Location

Viking Clinical Site #1008

Nashville, Tennessee, 37203, United States

Location

Viking Clinical Site #1047

Abilene, Texas, 79606, United States

Location

Viking Clinical Site #1063

Austin, Texas, 78131, United States

Location

Viking Clinical Site #1007

Austin, Texas, 78705, United States

Location

Viking Clinical Site #1091

Bellaire, Texas, 77401, United States

Location

Viking Clinical Site #1124

Brownsville, Texas, 78526, United States

Location

Viking Clinical Site #1049

Dallas, Texas, 75230, United States

Location

Viking Clinical Site #1048

Dallas, Texas, 75235, United States

Location

Viking Clinical Site #1111

Frisco, Texas, 75033, United States

Location

Viking Clinical Site #1046

Houston, Texas, 77040, United States

Location

Viking Clinical Site #1077

Lampasas, Texas, 76550, United States

Location

Viking Clinical Site #1143

San Antonio, Texas, 78215, United States

Location

Viking Clinical Site #1085

San Antonio, Texas, 78222, United States

Location

Viking Clinical Site #1073

San Antonio, Texas, 78229, United States

Location

Viking Clinical Site #1101

Waco, Texas, 76710, United States

Location

Viking Clinical Site #1002

Ogden, Utah, 84405, United States

Location

Viking Clinical Site #1092

Salt Lake City, Utah, 84107, United States

Location

Viking Clinical Site #1039

Sandy City, Utah, 84094, United States

Location

Viking Clinical Site #1024

St. George, Utah, 84790, United States

Location

Viking Clinical Site #1098

Arlington, Virginia, 22205, United States

Location

Viking Clinical Site #1082

Suffolk, Virginia, 23435, United States

Location

Viking Clinical Site #1072

Renton, Washington, 98057, United States

Location

Viking Clinical Site #1041

Spokane, Washington, 99218, United States

Location

Viking Clinical Site #1130

Mayagüez, 00680, Puerto Rico

Location

Viking Clinical Site #1086

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

PR (2); US (135)