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

NCT07104383 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VK2735-302
• Study Type: interventional
• Target: 1,100
• Locations: 2 countries
• Sites: 134

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 with Type 2 Diabetes who are obese or overweight

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline to Week 78 in body weight

  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) ≥27 kg/m2
• 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

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 (except for 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 mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
• Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM)
• 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
• 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
• Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• History of acute or chronic pancreatitis
• 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

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (134)

Viking Clinical Site #2037

Birmingham, Alabama, 35235, United States

RECRUITING

Viking Clinical Site #2064

Birmingham, Alabama, 35249, United States

RECRUITING

Viking Clinical Site #2128

Huntsville, Alabama, 35801, United States

RECRUITING

Viking Clinical Site #2081

Mobile, Alabama, 36608, United States

RECRUITING

Viking Clinical Site #2005

Chandler, Arizona, 85210, United States

RECRUITING

Viking Clinical Site #2017

Flagstaff, Arizona, 86001, United States

RECRUITING

Viking Clinical Site #2018

Peoria, Arizona, 85381, United States

RECRUITING

Viking Clinical Site #2135

Scottsdale, Arizona, 85260, United States

RECRUITING

Viking Clinical Site #2019

Tucson, Arizona, 85711, United States

RECRUITING

Viking Clinical Site #2036

Little Rock, Arkansas, 72211, United States

RECRUITING

Viking Clinical Site #2071

Chula Vista, California, 91911, United States

RECRUITING

Viking Clinical Site #2070

Escondido, California, 92025, United States

RECRUITING

Viking Clinical Site #2054

Huntington Park, California, 90255, United States

RECRUITING

Viking Clinical Site #2014

Lake Forest, California, 92630, United States

RECRUITING

Viking Clinical Site #2129

Lemon Grove, California, 91945, United States

RECRUITING

Viking Clinical Site #2051

Lincoln, California, 95648, United States

RECRUITING

Viking Clinical Site #2050

Long Beach, California, 90815, United States

RECRUITING

Viking Clinical Site #2055

Los Angeles, California, 90057, United States

RECRUITING

Viking Clinical Site #2078

Manteca, California, 95336, United States

RECRUITING

Viking Clinical Site #2053

Montclair, California, 91763, United States

RECRUITING

Viking Clinical Site #2068

Panorama City, California, 91402, United States

RECRUITING

Viking Clinical Site #2132

Rolling Hills Estates, California, 90274, United States

RECRUITING

Viking Clinical Site #2131

San Diego, California, 92103, United States

RECRUITING

Viking Clinical Site #2052

Spring Valley, California, 91978, United States

RECRUITING

Viking Clinical Site #2109

Tustin, California, 92780, United States

RECRUITING

Viking Clinical Site #2067

Van Nuys, California, 91405, United States

RECRUITING

Viking Clinical Site #2079

Walnut Creek, California, 94598, United States

RECRUITING

Viking Clinical Site #2119

Denver, Colorado, 80210, United States

RECRUITING

Viking Clinical Site #2123

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

RECRUITING

Viking Clinical Site #2013

Clearwater, Florida, 33756, United States

RECRUITING

Viking Clinical Site #2121

Clearwater, Florida, 33761, United States

RECRUITING

Viking Clinical Site #2003

Cooper City, Florida, 33024, United States

RECRUITING

Viking Clinical Site #2112

DeLand, Florida, 32720, United States

RECRUITING

Viking Clinical Site #2107

Delray Beach, Florida, 33445, United States

RECRUITING

Viking Clinical Site #2083

Fort Myers, Florida, 33912, United States

RECRUITING

Viking Clinical Site #2058

Jacksonville, Florida, 32216, United States

RECRUITING

Viking Clinical Site #2076

Lakeland, Florida, 33803, United States

RECRUITING

Viking Clinical Site #2060

Lakewood Rch, Florida, 34211, United States

RECRUITING

Viking Clinical Site #2117

Miami, Florida, 33122, United States

RECRUITING

Viking Clinical Site #2012

Ocoee, Florida, 34761, United States

RECRUITING

Viking Clinical Site #2056

Palmetto Bay, Florida, 33157, United States

RECRUITING

Viking Clinical Site #2011

Port Orange, Florida, 32127, United States

RECRUITING

Viking Clinical Site #2057

West Palm Beach, Florida, 33407, United States

RECRUITING

Viking Clinical Site #2116

Atlanta, Georgia, 30329, United States

RECRUITING

Viking Clinical Site #2030

Columbus, Georgia, 31904, United States

RECRUITING

Viking Clinical Site #2120

Rincon, Georgia, 31326, United States

RECRUITING

Viking Clinical Site #2093

Savannah, Georgia, 31406, United States

RECRUITING

Viking Clinical Site #2025

Woodstock, Georgia, 30189, United States

RECRUITING

Viking Clinical Site #2062

Honolulu, Hawaii, 96814, United States

RECRUITING

Viking Clinical Site #2080

Meridian, Idaho, 83642, United States

RECRUITING

Viking Clinical Site #2006

Chicago, Illinois, 60607, United States

RECRUITING

Viking Clinical Site #2146

Indianapolis, Indiana, 46202, United States

RECRUITING

Viking Clinical Site #2127

Valparaiso, Indiana, 46383, United States

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Viking Clinical Site #2147

Sioux City, Iowa, 68776, United States

RECRUITING

Viking Clinical Site #2022

West Des Moines, Iowa, 50266, United States

RECRUITING

Viking Clinical Site #2099

Wichita, Kansas, 67207, United States

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Viking Clinical Site #2069

Lexington, Kentucky, 40509, United States

RECRUITING

Viking Clinical Site #2040

Lexington, Kentucky, 40513, United States

RECRUITING

Viking Clinical Site #2009

Louisville, Kentucky, 40213, United States

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Viking Clinical Site #2118

Baton Rouge, Louisiana, 70808, United States

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Viking Clinical Site #2139

Baton Rouge, Louisiana, 70809, United States

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Viking Clinical Site #2106

Lafayette, Louisiana, 70508, United States

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Viking Clinical Site #2020

Metairie, Louisiana, 70006, United States

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Viking Clinical Site #2087

Monroe, Louisiana, 71201, United States

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Viking Clinical Site #2094

Chevy Chase, Maryland, 20815, United States

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Viking Clinical Site #2145

Rockville, Maryland, 20850, United States

RECRUITING

Viking Clinical Site #2066

Rockville, Maryland, 20854, United States

RECRUITING

Viking Clinical Site #2001

Methuen, Massachusetts, 01844, United States

RECRUITING

Viking Clinical Site #2100

Lansing, Michigan, 48912, United States

ACTIVE NOT RECRUITING

Viking Clinical Site #2038

Ypsilanti, Michigan, 48197, United States

RECRUITING

Viking Clinical Site #2140

Gulfport, Mississippi, 39503, United States

RECRUITING

Viking Clinical Site #2031

City of Saint Peters, Missouri, 63303, United States

RECRUITING

Viking Clinical Site #2016

Kansas City, Missouri, 64131, United States

RECRUITING

Viking Clinical Site #2125

Springfield, Missouri, 65807, United States

RECRUITING

Viking Clinical Site #2108

St Louis, Missouri, 63108, United States

ACTIVE NOT RECRUITING

Viking Clinical Site #2010

Butte, Montana, 59701, United States

RECRUITING

Viking Clinical Site #2075

Omaha, Nebraska, 68134, United States

RECRUITING

Viking Clinical Site #2035

Las Vegas, Nevada, 89148, United States

RECRUITING

Viking Clinical Site #2034

Reno, Nevada, 89511, United States

RECRUITING

Viking Clinical Site #2065

Lebanon, New Hampshire, 03756, United States

RECRUITING

Viking Clinical Site #2095

Marlton, New Jersey, 08009, United States

ACTIVE NOT RECRUITING

Viking Clinical Site #2029

Albuquerque, New Mexico, 87109, United States

RECRUITING

Viking Clinical Site #2088

Albany, New York, 12205, United States

RECRUITING

Viking Clinical Site #2042

East Syracuse, New York, 13057, United States

RECRUITING

Viking Clinical Site #2096

Hartsdale, New York, 10530, United States

RECRUITING

Viking Clinical Site #2133

New York, New York, 10036, United States

RECRUITING

Viking Clinical Site #2021

The Bronx, New York, 10455, United States

RECRUITING

Viking Clinical Site #2032

Westfield, New York, 14787, United States

RECRUITING

Viking Clinical Site #2141

Charlotte, North Carolina, 28205, United States

RECRUITING

Viking Clinical Site #2101

Fayetteville, North Carolina, 28304, United States

RECRUITING

Viking Clinical Site #2026

Greensboro, North Carolina, 27410, United States

RECRUITING

Viking Clinical Site #2110

Morehead City, North Carolina, 28557, United States

RECRUITING

Viking Clinical Site #2061

Morehead City, North Carolina, 28857, United States

RECRUITING

Viking Clinical Site #2115

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Viking Clinical Site #2027

Fargo, North Dakota, 58104, United States

RECRUITING

Viking Clinical Site #2043

Cincinnati, Ohio, 45219, United States

RECRUITING

Viking Clinical Site #2074

Cincinnati, Ohio, 45242, United States

RECRUITING

Viking Clinical Site #2044

Cleveland, Ohio, 44122, United States

RECRUITING

Viking Clinical Site #2089

Columbus, Ohio, 43215, United States

RECRUITING

Viking Clinical Site #2148

Dayton, Ohio, 45420, United States

RECRUITING

Viking Clinical Site #2113

Norman, Oklahoma, 73069, United States

RECRUITING

Viking Clinical Site #2137

Tulsa, Oklahoma, 74133, United States

RECRUITING

Viking Clinical Site #2097

Portland, Oregon, 97202, United States

RECRUITING

Viking Clinical Site #2126

Portland, Oregon, 97210, United States

RECRUITING

Viking Clinical Site #2045

East Greenwich, Rhode Island, 02818, United States

RECRUITING

Viking Clinical Site #2028

Greenville, South Carolina, 29607, United States

RECRUITING

Viking Clinical Site #2134

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Viking Clinical Site #2023

North Charleston, South Carolina, 29405, United States

RECRUITING

Viking Clinical Site #2004

Knoxville, Tennessee, 37909, United States

RECRUITING

Viking Clinical Site #2008

Nashville, Tennessee, 37203, United States

RECRUITING

Viking Clinical Site #2047

Abilene, Texas, 79606, United States

RECRUITING

Viking Clinical Site #2063

Austin, Texas, 78131, United States

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Viking Clinical Site #2007

Austin, Texas, 78705, United States

RECRUITING

Viking Clinical Site #2091

Bellaire, Texas, 77401, United States

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Viking Clinical Site #2124

Brownsville, Texas, 78526, United States

RECRUITING

Viking Clinical Site #2049

Dallas, Texas, 75230, United States

RECRUITING

Viking Clinical Site #2048

Dallas, Texas, 75235, United States

RECRUITING

Viking Clinical Site #2111

Frisco, Texas, 75033, United States

RECRUITING

Viking Clinical Site #2046

Houston, Texas, 77040, United States

RECRUITING

Viking Clinical Site #2077

Lampasas, Texas, 76550, United States

RECRUITING

Viking Clinical Site #2143

San Antonio, Texas, 78215, United States

RECRUITING

Viking Clinical Site #2085

San Antonio, Texas, 78222, United States

RECRUITING

Viking Clinical Site #2015

San Antonio, Texas, 78229, United States

RECRUITING

Viking Clinical Site #2102

Seabrook, Texas, 77586, United States

RECRUITING

Viking Clinical Site #2002

Ogden, Utah, 84405, United States

RECRUITING

Viking Clinical Site #2092

Salt Lake City, Utah, 84107, United States

RECRUITING

Viking Clinical Site #2039

Sandy City, Utah, 84094, United States

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Viking Clinical Site #2024

St. George, Utah, 84790, United States

RECRUITING

Viking Clinical Site #2098

Arlington, Virginia, 22205, United States

RECRUITING

Viking Clinical Site #2082

Suffolk, Virginia, 23435, United States

RECRUITING

Viking Clinical Site #2072

Renton, Washington, 98057, United States

RECRUITING

Viking Clinical Site #2041

Spokane, Washington, 99218, United States

RECRUITING

Viking Clinical Site #2130

Mayagüez, 00680, Puerto Rico

RECRUITING

Viking Clinical Site #2086

San Juan, 00927, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maris Johnson

CONTACT

Clinicaltrials@vikingtherapeutics.com

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: February 13, 2026

Record last verified: 2026-02

Locations

US (132); PR (2)