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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Assignment | Placebo Comparator | VK2735 Placebo Comparator Once Weekly |
|
| Active Assignment (Dose #1) | Experimental | VK2735 7.5mg Once Weekly |
|
| Active Assignment (Dose #2) | Experimental | VK2735 12.5mg Once Weekly |
|
| Active Assignment (Dose #3) | Experimental | VK2735 17.5mg Once Weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VK2735 | Drug | VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline to Week 78 in body weight | 78 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment | 78 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viking Clinical Site #2037 | Birmingham | Alabama | 35235 | United States | ||
| Viking Clinical Site #2064 |
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| Birmingham |
| Alabama |
| 35249 |
| United States |
| Viking Clinical Site #2128 | Huntsville | Alabama | 35801 | 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 #2135 | Scottsdale | Arizona | 85260 | United States |
| Viking Clinical Site #2019 | Tucson | Arizona | 85711 | United States |
| Viking Clinical Site #2036 | Little Rock | Arkansas | 72211 | 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 #2129 | Lemon Grove | California | 91945 | United States |
| Viking Clinical Site #2051 | Lincoln | California | 95648 | United States |
| Viking Clinical Site #2050 | Long Beach | California | 90815 | United States |
| Viking Clinical Site #2078 | Manteca | California | 95336 | United States |
| Viking Clinical Site #2053 | Montclair | California | 91763 | United States |
| Viking Clinical Site #2068 | Panorama City | California | 91402 | United States |
| Viking Clinical Site #2132 | Rolling Hills Estates | California | 90274 | United States |
| Viking Clinical Site #2131 | San Diego | California | 92103 | United States |
| Viking Clinical Site #2052 | Spring Valley | California | 91978 | 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 #2119 | Denver | Colorado | 80210 | United States |
| Viking Clinical Site #2013 | Clearwater | Florida | 33756 | United States |
| Viking Clinical Site #2121 | Clearwater | Florida | 33761 | 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 #2060 | Lakewood Rch | Florida | 34211 | United States |
| Viking Clinical Site #2117 | Miami | Florida | 33122 | 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 #2062 | Honolulu | Hawaii | 96814 | United States |
| Viking Clinical Site #2080 | Meridian | Idaho | 83642 | United States |
| Viking Clinical Site #2006 | Chicago | Illinois | 60607 | United States |
| Viking Clinical Site #2146 | Indianapolis | Indiana | 46202 | United States |
| Viking Clinical Site #2127 | Valparaiso | Indiana | 46383 | United States |
| Viking Clinical Site #2147 | Sioux City | Iowa | 68776 | 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 #2118 | Baton Rouge | Louisiana | 70808 | 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 #2087 | Monroe | Louisiana | 71201 | United States |
| Viking Clinical Site #2094 | Chevy Chase | Maryland | 20815 | United States |
| Viking Clinical Site #2145 | Rockville | Maryland | 20850 | United States |
| Viking Clinical Site #2066 | Rockville | Maryland | 20854 | United States |
| Viking Clinical Site #2001 | Methuen | Massachusetts | 01844 | United States |
| Viking Clinical Site #2038 | Ypsilanti | Michigan | 48197 | United States |
| Viking Clinical Site #2140 | Gulfport | Mississippi | 39503 | United States |
| Viking Clinical Site #2031 | City of Saint Peters | Missouri | 63303 | United States |
| Viking Clinical Site #2016 | Kansas City | Missouri | 64131 | 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 #2034 | Reno | Nevada | 89511 | United States |
| Viking Clinical Site #2065 | Lebanon | New Hampshire | 03756 | United States |
| Viking Clinical Site #2095 | Marlton | New Jersey | 08009 | 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 #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 #2101 | Fayetteville | North Carolina | 28304 | 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 #2061 | Morehead City | North Carolina | 28857 | United States |
| Viking Clinical Site #2115 | Winston-Salem | North Carolina | 27157 | 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 #2148 | Dayton | Ohio | 45420 | United States |
| Viking Clinical Site #2113 | Norman | Oklahoma | 73069 | United States |
| Viking Clinical Site #2137 | Tulsa | Oklahoma | 74133 | United States |
| Viking Clinical Site #2097 | Portland | Oregon | 97202 | 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 #2028 | Greenville | South Carolina | 29607 | 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 #2091 | Bellaire | Texas | 77401 | United States |
| Viking Clinical Site #2124 | Brownsville | Texas | 78526 | United States |
| Viking Clinical Site #2049 | Dallas | Texas | 75230 | United States |
| Viking Clinical Site #2048 | Dallas | Texas | 75235 | United States |
| Viking Clinical Site #2111 | Frisco | Texas | 75033 | United States |
| Viking Clinical Site #2046 | Houston | Texas | 77040 | United States |
| Viking Clinical Site #2077 | Lampasas | Texas | 76550 | United States |
| Viking Clinical Site #2143 | San Antonio | Texas | 78215 | United States |
| Viking Clinical Site #2085 | San Antonio | Texas | 78222 | United States |
| Viking Clinical Site #2015 | San Antonio | Texas | 78229 | United States |
| Viking Clinical Site #2102 | Seabrook | Texas | 77586 | United States |
| Viking Clinical Site #2002 | Ogden | Utah | 84405 | United States |
| Viking Clinical Site #2092 | Salt Lake City | Utah | 84107 | United States |
| Viking Clinical Site #2039 | Sandy City | Utah | 84094 | United States |
| Viking Clinical Site #2024 | St. George | Utah | 84790 | United States |
| Viking Clinical Site #2098 | Arlington | Virginia | 22205 | 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 |
| Viking Clinical Site #2130 | Mayagüez | 00680 | Puerto Rico |
| Viking Clinical Site #2086 | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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