RECRUITING

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

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Conditions

Weight Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-23
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07104383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years of age at the time of signing the informed consent
  2. 2. Body mass index (BMI) ≥27 kg/m2
  3. 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
  1. 1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  2. 2. Self-reported body weight change of 5% or more within 3 months of screening
  3. 3. Have a prior or planned surgical treatment for obesity (except for liposuction or abdominoplasty if performed \>1 year prior to screening)
  4. 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. 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. 6. Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening
  7. 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. 8. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
  9. 9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  10. 10. History of acute or chronic pancreatitis
  11. 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

Contacts and Locations

Study Contact

Maris Johnson
CONTACT
Clinicaltrials@vikingtherapeutics.com

Study Locations (Sites)

Viking Clinical Site #2037
Birmingham, Alabama, 35235
United States
Viking Clinical Site #2128
Huntsville, Alabama, 35801
United States
Viking Clinical Site #2081
Mobile, Alabama, 36608
United States
Viking Clinical Site #2005
Chandler, Arizona, 85210
United States
Viking Clinical Site #2017
Flagstaff, Arizona, 86001
United States
Viking Clinical Site #2018
Peoria, Arizona, 85381
United States
Viking Clinical Site #2019
Tucson, Arizona, 85711
United States
Viking Clinical Site #2071
Chula Vista, California, 91911
United States
Viking Clinical Site #2070
Escondido, California, 92025
United States
Viking Clinical Site #2054
Huntington Park, California, 90255
United States
Viking Clinical Site #2014
Lake Forest, California, 92630
United States
Viking Clinical Site #2051
Lincoln, California, 95648
United States
Viking Clinical Site #2050
Long Beach, California, 90815
United States
Viking Clinical Site #2055
Los Angeles, California, 90057
United States
Viking Clinical Site #2053
Montclair, California, 91763
United States
Viking Clinical Site #2068
Panorama City, California, 91402
United States
Viking Clinical Site #2109
Tustin, California, 92780
United States
Viking Clinical Site #2067
Van Nuys, California, 91405
United States
Viking Clinical Site #2079
Walnut Creek, California, 94598
United States
Viking Clinical Site #2013
Clearwater, Florida, 33756
United States
Viking Clinical Site #2003
Cooper City, Florida, 33024
United States
Viking Clinical Site #2112
DeLand, Florida, 32720
United States
Viking Clinical Site #2107
Delray Beach, Florida, 33445
United States
Viking Clinical Site #2083
Fort Myers, Florida, 33912
United States
Viking Clinical Site #2058
Jacksonville, Florida, 32216
United States
Viking Clinical Site #2076
Lakeland, Florida, 33803
United States
Viking Clinical Site #2012
Ocoee, Florida, 34761
United States
Viking Clinical Site #2056
Palmetto Bay, Florida, 33157
United States
Viking Clinical Site #2011
Port Orange, Florida, 32127
United States
Viking Clinical Site #2057
West Palm Beach, Florida, 33407
United States
Viking Clinical Site #2116
Atlanta, Georgia, 30329
United States
Viking Clinical Site #2030
Columbus, Georgia, 31904
United States
Viking Clinical Site #2120
Rincon, Georgia, 31326
United States
Viking Clinical Site #2093
Savannah, Georgia, 31406
United States
Viking Clinical Site #2025
Woodstock, Georgia, 30189
United States
Viking Clinical Site #2080
Meridian, Idaho, 83642
United States
Viking Clinical Site #2006
Chicago, Illinois, 60607
United States
Viking Clinical Site #2127
Valparaiso, Indiana, 46383
United States
Viking Clinical Site #2022
West Des Moines, Iowa, 50266
United States
Viking Clinical Site #2099
Wichita, Kansas, 67207
United States
Viking Clinical Site #2069
Lexington, Kentucky, 40509
United States
Viking Clinical Site #2040
Lexington, Kentucky, 40513
United States
Viking Clinical Site #2009
Louisville, Kentucky, 40213
United States
Viking Clinical Site #2139
Baton Rouge, Louisiana, 70809
United States
Viking Clinical Site #2106
Lafayette, Louisiana, 70508
United States
Viking Clinical Site #2020
Metairie, Louisiana, 70006
United States
Viking Clinical Site #2094
Chevy Chase, Maryland, 20815
United States
Viking Clinical Site #2066
Rockville, Maryland, 20854
United States
Viking Clinical Site #2001
Methuen, Massachusetts, 01844
United States
Viking Clinical Site #2140
Gulfport, Mississippi, 39503
United States
Viking Clinical Site #2016
Kansas City, Missouri, 64131
United States
Viking Clinical Site #2031
Saint Peters, Missouri, 63303
United States
Viking Clinical Site #2125
Springfield, Missouri, 65807
United States
Viking Clinical Site #2010
Butte, Montana, 59701
United States
Viking Clinical Site #2075
Omaha, Nebraska, 68134
United States
Viking Clinical Site #2035
Las Vegas, Nevada, 89148
United States
Viking Clinical Site #2029
Albuquerque, New Mexico, 87109
United States
Viking Clinical Site #2088
Albany, New York, 12205
United States
Viking Clinical Site #2021
Bronx, New York, 10455
United States
Viking Clinical Site #2042
East Syracuse, New York, 13057
United States
Viking Clinical Site #2096
Hartsdale, New York, 10530
United States
Viking Clinical Site #2133
New York, New York, 10036
United States
Viking Clinical Site #2032
Westfield, New York, 14787
United States
Viking Clinical Site #2141
Charlotte, North Carolina, 28205
United States
Viking Clinical Site #2026
Greensboro, North Carolina, 27410
United States
Viking Clinical Site #2110
Morehead City, North Carolina, 28557
United States
Viking Clinical Site #2027
Fargo, North Dakota, 58104
United States
Viking Clinical Site #2043
Cincinnati, Ohio, 45219
United States
Viking Clinical Site #2074
Cincinnati, Ohio, 45242
United States
Viking Clinical Site #2044
Cleveland, Ohio, 44122
United States
Viking Clinical Site #2089
Columbus, Ohio, 43215
United States
Viking Clinical Site #2137
Tulsa, Oklahoma, 74133
United States
Viking Clinical Site #2126
Portland, Oregon, 97210
United States
Viking Clinical Site #2045
East Greenwich, Rhode Island, 02818
United States
Viking Clinical Site #2134
Myrtle Beach, South Carolina, 29572
United States
Viking Clinical Site #2023
North Charleston, South Carolina, 29405
United States
Viking Clinical Site #2004
Knoxville, Tennessee, 37909
United States
Viking Clinical Site #2008
Nashville, Tennessee, 37203
United States
Viking Clinical Site #2047
Abilene, Texas, 79606
United States
Viking Clinical Site #2063
Austin, Texas, 78131
United States
Viking Clinical Site #2007
Austin, Texas, 78705
United States
Viking Clinical Site #2049
Dallas, Texas, 75230
United States
Viking Clinical Site #2048
Dallas, Texas, 75235
United States
Viking Clinical Site #2046
Houston, Texas, 77040
United States
Viking Clinical Site #2077
Lampasas, Texas, 76550
United States
Viking Clinical Site #2015
San Antonio, Texas, 78229
United States
Viking Clinical Site #2102
Seabrook, Texas, 77586
United States
Viking Clinical Site #2024
Saint George, Utah, 84790
United States
Viking Clinical Site #2092
Salt Lake City, Utah, 84107
United States
Viking Clinical Site #2082
Suffolk, Virginia, 23435
United States
Viking Clinical Site #2072
Renton, Washington, 98057
United States
Viking Clinical Site #2041
Spokane, Washington, 99218
United States

Collaborators and Investigators

Sponsor: Viking Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2027-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Weight Loss