| Condition or Disease | Intervention/Treatment |
|---|---|
Weight Loss | Drug: VK2735Drug: VK2735Drug: VK2735Drug: VK2735 |
ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Weight Loss | Drug: VK2735Drug: VK2735Drug: VK2735Drug: VK2735 |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 1100 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | June 22, 2025 |
| Actual Primary Completion Date | 1yr 1mo from now |
| Actual Study Completion Date | 1yr 2mos from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| 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 |
| Sponsors and Collaborators | Viking Therapeutics, Inc. |
|---|---|
| Locations | Viking Clinical Site #2037 | Birmingham Alabama, United States, 35235Viking Clinical Site #2064 | Birmingham Alabama, United States, 35249Viking Clinical Site #2128 | Huntsville Alabama, United States, 35801Viking Clinical Site #2005 | Chandler Arizona, United States, 85210Viking Clinical Site #2017 | Flagstaff Arizona, United States, 86001Viking Clinical Site #2018 | Peoria Arizona, United States, 85381Viking Clinical Site #2135 | Scottsdale Arizona, United States, 85260Viking Clinical Site #2019 | Tucson Arizona, United States, 85711Viking Clinical Site #2036 | Little Rock Arkansas, United States, 72211Viking Clinical Site #2071 | Chula Vista California, United States, 91911Viking Clinical Site #2070 | Escondido California, United States, 92025Viking Clinical Site #2054 | Huntington Park California, United States, 90255Viking Clinical Site #2014 | Lake Forest California, United States, 92630Viking Clinical Site #2129 | Lemon Grove California, United States, 91945Viking Clinical Site #2051 | Lincoln California, United States, 95648Viking Clinical Site #2050 | Long Beach California, United States, 90815Viking Clinical Site #2078 | Manteca California, United States, 95336Viking Clinical Site #2053 | Montclair California, United States, 91763Viking Clinical Site #2068 | Panorama City California, United States, 91402Viking Clinical Site #2132 | Rolling Hills Estates California, United States, 90274Viking Clinical Site #2131 | San Diego California, United States, 92103Viking Clinical Site #2052 | Spring Valley California, United States, 91978Viking Clinical Site #2109 | Tustin California, United States, 92780Viking Clinical Site #2067 | Van Nuys California, United States, 91405Viking Clinical Site #2079 | Walnut Creek California, United States, 94598Viking Clinical Site #2119 | Denver Colorado, United States, 80210Viking Clinical Site #2013 | Clearwater Florida, United States, 33756Viking Clinical Site #2121 | Clearwater Florida, United States, 33761Viking Clinical Site #2003 | Cooper City Florida, United States, 33024Viking Clinical Site #2112 | DeLand Florida, United States, 32720Viking Clinical Site #2107 | Delray Beach Florida, United States, 33445Viking Clinical Site #2083 | Fort Myers Florida, United States, 33912Viking Clinical Site #2058 | Jacksonville Florida, United States, 32216Viking Clinical Site #2076 | Lakeland Florida, United States, 33803Viking Clinical Site #2060 | Lakewood Rch Florida, United States, 34211Viking Clinical Site #2117 | Miami Florida, United States, 33122Viking Clinical Site #2012 | Ocoee Florida, United States, 34761Viking Clinical Site #2056 | Palmetto Bay Florida, United States, 33157Viking Clinical Site #2011 | Port Orange Florida, United States, 32127Viking Clinical Site #2057 | West Palm Beach Florida, United States, 33407Viking Clinical Site #2116 | Atlanta Georgia, United States, 30329Viking Clinical Site #2030 | Columbus Georgia, United States, 31904Viking Clinical Site #2120 | Rincon Georgia, United States, 31326Viking Clinical Site #2093 | Savannah Georgia, United States, 31406Viking Clinical Site #2025 | Woodstock Georgia, United States, 30189Viking Clinical Site #2062 | Honolulu Hawaii, United States, 96814Viking Clinical Site #2080 | Meridian Idaho, United States, 83642Viking Clinical Site #2006 | Chicago Illinois, United States, 60607Viking Clinical Site #2146 | Indianapolis Indiana, United States, 46202Viking Clinical Site #2127 | Valparaiso Indiana, United States, 46383Viking Clinical Site #2147 | Sioux City Iowa, United States, 68776Viking Clinical Site #2022 | West Des Moines Iowa, United States, 50266Viking Clinical Site #2099 | Wichita Kansas, United States, 67207Viking Clinical Site #2069 | Lexington Kentucky, United States, 40509Viking Clinical Site #2040 | Lexington Kentucky, United States, 40513Viking Clinical Site #2009 | Louisville Kentucky, United States, 40213Viking Clinical Site #2118 | Baton Rouge Louisiana, United States, 70808Viking Clinical Site #2139 | Baton Rouge Louisiana, United States, 70809Viking Clinical Site #2106 | Lafayette Louisiana, United States, 70508Viking Clinical Site #2020 | Metairie Louisiana, United States, 70006Viking Clinical Site #2087 | Monroe Louisiana, United States, 71201Viking Clinical Site #2094 | Chevy Chase Maryland, United States, 20815Viking Clinical Site #2145 | Rockville Maryland, United States, 20850Viking Clinical Site #2066 | Rockville Maryland, United States, 20854Viking Clinical Site #2001 | Methuen Massachusetts, United States, 01844Viking Clinical Site #2038 | Ypsilanti Michigan, United States, 48197Viking Clinical Site #2140 | Gulfport Mississippi, United States, 39503Viking Clinical Site #2031 | City of Saint Peters Missouri, United States, 63303Viking Clinical Site #2016 | Kansas City Missouri, United States, 64131Viking Clinical Site #2125 | Springfield Missouri, United States, 65807Viking Clinical Site #2010 | Butte Montana, United States, 59701Viking Clinical Site #2075 | Omaha Nebraska, United States, 68134Viking Clinical Site #2035 | Las Vegas Nevada, United States, 89148Viking Clinical Site #2034 | Reno Nevada, United States, 89511Viking Clinical Site #2065 | Lebanon New Hampshire, United States, 03756Viking Clinical Site #2095 | Marlton New Jersey, United States, 08009Viking Clinical Site #2029 | Albuquerque New Mexico, United States, 87109Viking Clinical Site #2088 | Albany New York, United States, 12205Viking Clinical Site #2096 | Hartsdale New York, United States, 10530Viking Clinical Site #2133 | New York New York, United States, 10036Viking Clinical Site #2032 | Westfield New York, United States, 14787Viking Clinical Site #2141 | Charlotte North Carolina, United States, 28205Viking Clinical Site #2101 | Fayetteville North Carolina, United States, 28304Viking Clinical Site #2026 | Greensboro North Carolina, United States, 27410Viking Clinical Site #2110 | Morehead City North Carolina, United States, 28557Viking Clinical Site #2061 | Morehead City North Carolina, United States, 28857Viking Clinical Site #2115 | Winston-Salem North Carolina, United States, 27157Viking Clinical Site #2027 | Fargo North Dakota, United States, 58104Viking Clinical Site #2043 | Cincinnati Ohio, United States, 45219Viking Clinical Site #2074 | Cincinnati Ohio, United States, 45242Viking Clinical Site #2044 | Cleveland Ohio, United States, 44122Viking Clinical Site #2089 | Columbus Ohio, United States, 43215Viking Clinical Site #2148 | Dayton Ohio, United States, 45420Viking Clinical Site #2113 | Norman Oklahoma, United States, 73069Viking Clinical Site #2137 | Tulsa Oklahoma, United States, 74133Viking Clinical Site #2097 | Portland Oregon, United States, 97202Viking Clinical Site #2126 | Portland Oregon, United States, 97210Viking Clinical Site #2045 | East Greenwich Rhode Island, United States, 02818Viking Clinical Site #2028 | Greenville South Carolina, United States, 29607Viking Clinical Site #2134 | Myrtle Beach South Carolina, United States, 29572Viking Clinical Site #2023 | North Charleston South Carolina, United States, 29405Viking Clinical Site #2004 | Knoxville Tennessee, United States, 37909Viking Clinical Site #2008 | Nashville Tennessee, United States, 37203Viking Clinical Site #2047 | Abilene Texas, United States, 79606Viking Clinical Site #2063 | Austin Texas, United States, 78131Viking Clinical Site #2007 | Austin Texas, United States, 78705Viking Clinical Site #2091 | Bellaire Texas, United States, 77401Viking Clinical Site #2124 | Brownsville Texas, United States, 78526Viking Clinical Site #2049 | Dallas Texas, United States, 75230Viking Clinical Site #2048 | Dallas Texas, United States, 75235Viking Clinical Site #2111 | Frisco Texas, United States, 75033Viking Clinical Site #2046 | Houston Texas, United States, 77040Viking Clinical Site #2077 | Lampasas Texas, United States, 76550Viking Clinical Site #2143 | San Antonio Texas, United States, 78215Viking Clinical Site #2085 | San Antonio Texas, United States, 78222Viking Clinical Site #2015 | San Antonio Texas, United States, 78229Viking Clinical Site #2102 | Seabrook Texas, United States, 77586Viking Clinical Site #2002 | Ogden Utah, United States, 84405Viking Clinical Site #2092 | Salt Lake City Utah, United States, 84107Viking Clinical Site #2039 | Sandy City Utah, United States, 84094Viking Clinical Site #2024 | St. George Utah, United States, 84790Viking Clinical Site #2098 | Arlington Virginia, United States, 22205Viking Clinical Site #2082 | Suffolk Virginia, United States, 23435Viking Clinical Site #2072 | Renton Washington, United States, 98057Viking Clinical Site #2041 | Spokane Washington, United States, 99218Viking Clinical Site #2130 | Mayagüez , Puerto Rico, 00680Viking Clinical Site #2086 | San Juan , Puerto Rico, 00927 |
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