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ACTIVE NOT RECRUITING

NCT07104383

PHASE3

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

Sponsor: Viking Therapeutics, Inc.

View on ClinicalTrials.gov

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 with Type 2 Diabetes who are obese or overweight

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 With Type 2 Diabetes Who Are Obese, or Overweight

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1100

Start Date

2025-06-23

Completion Date

2027-08-01

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Weight Loss

Interventions

DRUG

VK2735

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

Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent 2. Body mass index (BMI) ≥27 kg/m2 3. Have Type 2 Diabetes Mellitus according to the American Diabetes Association with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Type 2 diabetes mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists 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 (except for 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 mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line) 5. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM) 6. Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening • Note: Severe hypoglycemia episodes should be considered when severe cognitive impairment requiring the assistance of another person occurs and the administration of carbohydrate, glucagon, or other resuscitative actions are required. Blood glucose (BG) measurements may not be available during such an event, but neurological recovery attributable to the restoration of BG to normal is considered sufficient evidence that the event was induced by a low BG concentration. If BG measurements are available, the levels associated with severe hypoglycemia are BG \< 54 mg/dL 7. Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \> 270 mg/dL (on 2 non-consecutive days) within 4 weeks prior to randomization 8. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment 9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) 10. History of acute or chronic pancreatitis 11. Thyroid disease that is not controlled (Thyroid stimulating hormone (TSH) outside normal range by central lab at screening; one repetition during screening is allowed). Participants with previous history of partial/total thyroidectomy or hypothyroidism may be included, provided their hormone replacement dose has been stable for 3 months prior to screening

Locations (127)

Viking Clinical Site #2037

Birmingham, Alabama, United States

Viking Clinical Site #2064

Birmingham, Alabama, United States

Viking Clinical Site #2128

Huntsville, Alabama, United States

Viking Clinical Site #2005

Chandler, Arizona, United States

Viking Clinical Site #2017

Flagstaff, Arizona, United States

Viking Clinical Site #2018

Peoria, Arizona, United States

Viking Clinical Site #2135

Scottsdale, Arizona, United States

Viking Clinical Site #2019

Tucson, Arizona, United States

Viking Clinical Site #2036

Little Rock, Arkansas, United States

Viking Clinical Site #2071

Chula Vista, California, United States

Viking Clinical Site #2070

Escondido, California, United States

Viking Clinical Site #2054

Huntington Park, California, United States

Viking Clinical Site #2014

Lake Forest, California, United States

Viking Clinical Site #2129

Lemon Grove, California, United States

Viking Clinical Site #2051

Lincoln, California, United States

Viking Clinical Site #2050

Long Beach, California, United States

Viking Clinical Site #2078

Manteca, California, United States

Viking Clinical Site #2053

Montclair, California, United States

Viking Clinical Site #2068

Panorama City, California, United States

Viking Clinical Site #2132

Rolling Hills Estates, California, United States

Viking Clinical Site #2131

San Diego, California, United States

Viking Clinical Site #2052

Spring Valley, California, United States

Viking Clinical Site #2109

Tustin, California, United States

Viking Clinical Site #2067

Van Nuys, California, United States

Viking Clinical Site #2079

Walnut Creek, California, United States

Viking Clinical Site #2119

Denver, Colorado, United States

Viking Clinical Site #2013

Clearwater, Florida, United States

Viking Clinical Site #2121

Clearwater, Florida, United States

Viking Clinical Site #2003

Cooper City, Florida, United States

Viking Clinical Site #2112

DeLand, Florida, United States

Viking Clinical Site #2107

Delray Beach, Florida, United States

Viking Clinical Site #2083

Fort Myers, Florida, United States

Viking Clinical Site #2058

Jacksonville, Florida, United States

Viking Clinical Site #2076

Lakeland, Florida, United States

Viking Clinical Site #2060

Lakewood Rch, Florida, United States

Viking Clinical Site #2117

Miami, Florida, United States

Viking Clinical Site #2012

Ocoee, Florida, United States

Viking Clinical Site #2056

Palmetto Bay, Florida, United States

Viking Clinical Site #2011

Port Orange, Florida, United States

Viking Clinical Site #2057

West Palm Beach, Florida, United States

Viking Clinical Site #2116

Atlanta, Georgia, United States

Viking Clinical Site #2030

Columbus, Georgia, United States

Viking Clinical Site #2120

Rincon, Georgia, United States

Viking Clinical Site #2093

Savannah, Georgia, United States

Viking Clinical Site #2025

Woodstock, Georgia, United States

Viking Clinical Site #2062

Honolulu, Hawaii, United States

Viking Clinical Site #2080

Meridian, Idaho, United States

Viking Clinical Site #2006

Chicago, Illinois, United States

Viking Clinical Site #2146

Indianapolis, Indiana, United States

Viking Clinical Site #2127

Valparaiso, Indiana, United States

Viking Clinical Site #2147

Sioux City, Iowa, United States

Viking Clinical Site #2022

West Des Moines, Iowa, United States

Viking Clinical Site #2099

Wichita, Kansas, United States

Viking Clinical Site #2069

Lexington, Kentucky, United States

Viking Clinical Site #2040

Lexington, Kentucky, United States

Viking Clinical Site #2009

Louisville, Kentucky, United States

Viking Clinical Site #2118

Baton Rouge, Louisiana, United States

Viking Clinical Site #2139

Baton Rouge, Louisiana, United States

Viking Clinical Site #2106

Lafayette, Louisiana, United States

Viking Clinical Site #2020

Metairie, Louisiana, United States

Viking Clinical Site #2087

Monroe, Louisiana, United States

Viking Clinical Site #2094

Chevy Chase, Maryland, United States

Viking Clinical Site #2145

Rockville, Maryland, United States

Viking Clinical Site #2066

Rockville, Maryland, United States

Viking Clinical Site #2001

Methuen, Massachusetts, United States

Viking Clinical Site #2038

Ypsilanti, Michigan, United States

Viking Clinical Site #2140

Gulfport, Mississippi, United States

Viking Clinical Site #2031

City of Saint Peters, Missouri, United States

Viking Clinical Site #2016

Kansas City, Missouri, United States

Viking Clinical Site #2125

Springfield, Missouri, United States

Viking Clinical Site #2010

Butte, Montana, United States

Viking Clinical Site #2075

Omaha, Nebraska, United States

Viking Clinical Site #2035

Las Vegas, Nevada, United States

Viking Clinical Site #2034

Reno, Nevada, United States

Viking Clinical Site #2065

Lebanon, New Hampshire, United States

Viking Clinical Site #2095

Marlton, New Jersey, United States

Viking Clinical Site #2029

Albuquerque, New Mexico, United States

Viking Clinical Site #2088

Albany, New York, United States

Viking Clinical Site #2096

Hartsdale, New York, United States

Viking Clinical Site #2133

New York, New York, United States

Viking Clinical Site #2032

Westfield, New York, United States

Viking Clinical Site #2141

Charlotte, North Carolina, United States

Viking Clinical Site #2101

Fayetteville, North Carolina, United States

Viking Clinical Site #2026

Greensboro, North Carolina, United States

Viking Clinical Site #2110

Morehead City, North Carolina, United States

Viking Clinical Site #2061

Morehead City, North Carolina, United States

Viking Clinical Site #2115

Winston-Salem, North Carolina, United States

Viking Clinical Site #2027

Fargo, North Dakota, United States

Viking Clinical Site #2043

Cincinnati, Ohio, United States

Viking Clinical Site #2074

Cincinnati, Ohio, United States

Viking Clinical Site #2044

Cleveland, Ohio, United States

Viking Clinical Site #2089

Columbus, Ohio, United States

Viking Clinical Site #2148

Dayton, Ohio, United States

Viking Clinical Site #2113

Norman, Oklahoma, United States

Viking Clinical Site #2137

Tulsa, Oklahoma, United States

Viking Clinical Site #2097

Portland, Oregon, United States

Viking Clinical Site #2126

Portland, Oregon, United States

Viking Clinical Site #2045

East Greenwich, Rhode Island, United States

Viking Clinical Site #2028

Greenville, South Carolina, United States

Viking Clinical Site #2134

Myrtle Beach, South Carolina, United States

Viking Clinical Site #2023

North Charleston, South Carolina, United States

Viking Clinical Site #2004

Knoxville, Tennessee, United States

Viking Clinical Site #2008

Nashville, Tennessee, United States

Viking Clinical Site #2047

Abilene, Texas, United States

Viking Clinical Site #2063

Austin, Texas, United States

Viking Clinical Site #2007

Austin, Texas, United States

Viking Clinical Site #2091

Bellaire, Texas, United States

Viking Clinical Site #2124

Brownsville, Texas, United States

Viking Clinical Site #2049

Dallas, Texas, United States

Viking Clinical Site #2048

Dallas, Texas, United States

Viking Clinical Site #2111

Frisco, Texas, United States

Viking Clinical Site #2046

Houston, Texas, United States

Viking Clinical Site #2077

Lampasas, Texas, United States

Viking Clinical Site #2143

San Antonio, Texas, United States

Viking Clinical Site #2085

San Antonio, Texas, United States

Viking Clinical Site #2015

San Antonio, Texas, United States

Viking Clinical Site #2102

Seabrook, Texas, United States

Viking Clinical Site #2002

Ogden, Utah, United States

Viking Clinical Site #2092

Salt Lake City, Utah, United States

Viking Clinical Site #2039

Sandy City, Utah, United States

Viking Clinical Site #2024

St. George, Utah, United States

Viking Clinical Site #2098

Arlington, Virginia, United States

Viking Clinical Site #2082

Suffolk, Virginia, United States

Viking Clinical Site #2072

Renton, Washington, United States

Viking Clinical Site #2041

Spokane, Washington, United States

Viking Clinical Site #2130

Mayagüez, Puerto Rico

Viking Clinical Site #2086

San Juan, Puerto Rico

Clinical Research Directory

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)