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

Status: Recruiting
Location: See all (126) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Viking Clinical Site #2037
RECRUITING
Birmingham
Viking Clinical Site #2064
RECRUITING
Birmingham
Viking Clinical Site #2128
RECRUITING
Huntsville
Viking Clinical Site #2081
RECRUITING
Mobile
Arkansas
Viking Clinical Site #2036
RECRUITING
Little Rock
Arizona
Viking Clinical Site #2005
RECRUITING
Chandler
Viking Clinical Site #2017
RECRUITING
Flagstaff
Viking Clinical Site #2018
RECRUITING
Peoria
Viking Clinical Site #2135
RECRUITING
Scottsdale
Viking Clinical Site #2019
RECRUITING
Tucson
California
Viking Clinical Site #2071
RECRUITING
Chula Vista
Viking Clinical Site #2070
RECRUITING
Escondido
Viking Clinical Site #2054
RECRUITING
Huntington Park
Viking Clinical Site #2014
RECRUITING
Lake Forest
Viking Clinical Site #2129
RECRUITING
Lemon Grove
Viking Clinical Site #2051
RECRUITING
Lincoln
Viking Clinical Site #2050
RECRUITING
Long Beach
Viking Clinical Site #2055
RECRUITING
Los Angeles
Viking Clinical Site #2078
RECRUITING
Manteca
Viking Clinical Site #2053
RECRUITING
Montclair
Viking Clinical Site #2068
RECRUITING
Panorama City
Viking Clinical Site #2132
RECRUITING
Rolling Hills Estates
Viking Clinical Site #2131
RECRUITING
San Diego
Viking Clinical Site #2052
RECRUITING
Spring Valley
Viking Clinical Site #2109
RECRUITING
Tustin
Viking Clinical Site #2067
RECRUITING
Van Nuys
Viking Clinical Site #2079
RECRUITING
Walnut Creek
Colorado
Viking Clinical Site #2119
RECRUITING
Denver
Washington, D.c.
Viking Clinical Site #2123
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Viking Clinical Site #2013
RECRUITING
Clearwater
Viking Clinical Site #2121
RECRUITING
Clearwater
Viking Clinical Site #2003
RECRUITING
Cooper City
Viking Clinical Site #2112
RECRUITING
Deland
Viking Clinical Site #2107
RECRUITING
Delray Beach
Viking Clinical Site #2083
RECRUITING
Fort Myers
Viking Clinical Site #2058
RECRUITING
Jacksonville
Viking Clinical Site #2076
RECRUITING
Lakeland
Viking Clinical Site #2060
RECRUITING
Lakewood Rch
Viking Clinical Site #2012
RECRUITING
Ocoee
Viking Clinical Site #2056
RECRUITING
Palmetto Bay
Viking Clinical Site #2011
RECRUITING
Port Orange
Viking Clinical Site #2057
RECRUITING
West Palm Beach
Georgia
Viking Clinical Site #2116
RECRUITING
Atlanta
Viking Clinical Site #2030
RECRUITING
Columbus
Viking Clinical Site #2120
RECRUITING
Rincon
Viking Clinical Site #2093
RECRUITING
Savannah
Viking Clinical Site #2025
RECRUITING
Woodstock
Hawaii
Viking Clinical Site #2062
RECRUITING
Honolulu
Iowa
Viking Clinical Site #2022
RECRUITING
West Des Moines
Idaho
Viking Clinical Site #2080
RECRUITING
Meridian
Illinois
Viking Clinical Site #2006
RECRUITING
Chicago
Indiana
Viking Clinical Site #2127
RECRUITING
Valparaiso
Kansas
Viking Clinical Site #2099
RECRUITING
Wichita
Kentucky
Viking Clinical Site #2040
RECRUITING
Lexington
Viking Clinical Site #2069
RECRUITING
Lexington
Viking Clinical Site #2009
RECRUITING
Louisville
Louisiana
Viking Clinical Site #2118
ACTIVE_NOT_RECRUITING
Baton Rouge
Viking Clinical Site #2139
RECRUITING
Baton Rouge
Viking Clinical Site #2106
RECRUITING
Lafayette
Viking Clinical Site #2020
RECRUITING
Metairie
Viking Clinical Site #2087
RECRUITING
Monroe
Massachusetts
Viking Clinical Site #2001
RECRUITING
Methuen
Maryland
Viking Clinical Site #2094
RECRUITING
Chevy Chase
Viking Clinical Site #2066
RECRUITING
Rockville
Michigan
Viking Clinical Site #2100
ACTIVE_NOT_RECRUITING
Lansing
Viking Clinical Site #2038
RECRUITING
Ypsilanti
Missouri
Viking Clinical Site #2031
RECRUITING
City Of Saint Peters
Viking Clinical Site #2016
RECRUITING
Kansas City
Viking Clinical Site #2125
RECRUITING
Springfield
Mississippi
Viking Clinical Site #2140
RECRUITING
Gulfport
Montana
Viking Clinical Site #2010
RECRUITING
Butte
North Carolina
Viking Clinical Site #2141
RECRUITING
Charlotte
Viking Clinical Site #2101
RECRUITING
Fayetteville
Viking Clinical Site #2026
RECRUITING
Greensboro
Viking Clinical Site #2061
RECRUITING
Morehead City
Viking Clinical Site #2110
RECRUITING
Morehead City
North Dakota
Viking Clinical Site #2027
RECRUITING
Fargo
Nebraska
Viking Clinical Site #2075
RECRUITING
Omaha
New Jersey
Viking Clinical Site #2095
ACTIVE_NOT_RECRUITING
Marlton
New Mexico
Viking Clinical Site #2029
RECRUITING
Albuquerque
Nevada
Viking Clinical Site #2035
RECRUITING
Las Vegas
Viking Clinical Site #2034
ACTIVE_NOT_RECRUITING
Reno
New York
Viking Clinical Site #2088
RECRUITING
Albany
Viking Clinical Site #2042
RECRUITING
East Syracuse
Viking Clinical Site #2096
RECRUITING
Hartsdale
Viking Clinical Site #2133
RECRUITING
New York
Viking Clinical Site #2021
RECRUITING
The Bronx
Viking Clinical Site #2032
RECRUITING
Westfield
Ohio
Viking Clinical Site #2043
RECRUITING
Cincinnati
Viking Clinical Site #2074
RECRUITING
Cincinnati
Viking Clinical Site #2044
RECRUITING
Cleveland
Viking Clinical Site #2089
RECRUITING
Columbus
Oklahoma
Viking Clinical Site #2113
RECRUITING
Norman
Viking Clinical Site #2137
RECRUITING
Tulsa
Oregon
Viking Clinical Site #2097
RECRUITING
Portland
Viking Clinical Site #2126
RECRUITING
Portland
Rhode Island
Viking Clinical Site #2045
RECRUITING
East Greenwich
South Carolina
Viking Clinical Site #2028
RECRUITING
Greenville
Viking Clinical Site #2134
RECRUITING
Myrtle Beach
Viking Clinical Site #2023
RECRUITING
North Charleston
Tennessee
Viking Clinical Site #2004
RECRUITING
Knoxville
Viking Clinical Site #2008
RECRUITING
Nashville
Texas
Viking Clinical Site #2047
RECRUITING
Abilene
Viking Clinical Site #2007
RECRUITING
Austin
Viking Clinical Site #2063
RECRUITING
Austin
Viking Clinical Site #2091
RECRUITING
Bellaire
Viking Clinical Site #2124
RECRUITING
Brownsville
Viking Clinical Site #2048
RECRUITING
Dallas
Viking Clinical Site #2049
RECRUITING
Dallas
Viking Clinical Site #2111
RECRUITING
Frisco
Viking Clinical Site #2046
RECRUITING
Houston
Viking Clinical Site #2077
RECRUITING
Lampasas
Viking Clinical Site #2015
RECRUITING
San Antonio
Viking Clinical Site #2085
RECRUITING
San Antonio
Viking Clinical Site #2143
RECRUITING
San Antonio
Viking Clinical Site #2102
RECRUITING
Seabrook
Utah
Viking Clinical Site #2002
RECRUITING
Ogden
Viking Clinical Site #2092
RECRUITING
Salt Lake City
Viking Clinical Site #2039
RECRUITING
Sandy City
Viking Clinical Site #2024
RECRUITING
St. George
Virginia
Viking Clinical Site #2098
ACTIVE_NOT_RECRUITING
Arlington
Viking Clinical Site #2082
RECRUITING
Suffolk
Washington
Viking Clinical Site #2072
RECRUITING
Renton
Viking Clinical Site #2041
RECRUITING
Spokane
Other Locations
Puerto Rico
Viking Clinical Site #2130
RECRUITING
Mayagüez
Viking Clinical Site #2086
RECRUITING
San Juan
Contact Information
Primary
Maris Johnson
Clinicaltrials@vikingtherapeutics.com
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 1100
Treatments
Placebo_comparator: Placebo Assignment
VK2735 Placebo Comparator Once Weekly
Experimental: Active Assignment (Dose #1)
VK2735 7.5mg Once Weekly
Experimental: Active Assignment (Dose #2)
VK2735 12.5mg Once Weekly
Experimental: Active Assignment (Dose #3)
VK2735 17.5mg Once Weekly
Related Therapeutic Areas
Sponsors
Leads: Viking Therapeutics, Inc.

This content was sourced from clinicaltrials.gov