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

Purpose

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

Condition

  • Weight Loss

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Assignment 		VK2735 Placebo Comparator Once Weekly
  • Drug: VK2735
    VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
Experimental
Active Assignment (Dose #1) 		VK2735 7.5mg Once Weekly
  • Drug: VK2735
    VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
Experimental
Active Assignment (Dose #2) 		VK2735 12.5mg Once Weekly
  • Drug: VK2735
    VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
Experimental
Active Assignment (Dose #3) 		VK2735 17.5mg Once Weekly
  • Drug: VK2735
    VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Recruiting Locations

Viking Clinical Site #2037
Birmingham 4049979, Alabama 4829764 35235
Contact:
205-833-2228

Viking Clinical Site #2064
Birmingham 4049979, Alabama 4829764 35249
Contact:
205-975-8217

Viking Clinical Site #2128
Huntsville 4068590, Alabama 4829764 35801
Contact:
256-533-6603

Viking Clinical Site #2081
Mobile 4076598, Alabama 4829764 36608
Contact:
251-414-1984

Viking Clinical Site #2005
Chandler 5289282, Arizona 5551752 85210
Contact:
480-470-4000

Viking Clinical Site #2017
Flagstaff 5294810, Arizona 5551752 86001
Contact:
480-470-4000

Viking Clinical Site #2018
Peoria 5308480, Arizona 5551752 85381
Contact:
480-470-4000

Viking Clinical Site #2135
Scottsdale 5313457, Arizona 5551752 85260
Contact:
480-725-8708

Viking Clinical Site #2019
Tucson 5318313, Arizona 5551752 85711
Contact:
520-636-5000

Viking Clinical Site #2036
Little Rock 4119403, Arkansas 4099753 72211
Contact:
501-221-8681

Viking Clinical Site #2071
Chula Vista 5336899, California 5332921 91911
Contact:
619-955-5246

Viking Clinical Site #2070
Escondido 5346827, California 5332921 92025
Contact:
760-466-1538

Viking Clinical Site #2054
Huntington Park 5358736, California 5332921 90255
Contact:
323-588-1968

Viking Clinical Site #2014
Lake Forest 5364514, California 5332921 92630
Contact:
714-550-9990

Viking Clinical Site #2129
Lemon Grove 5365893, California 5332921 91945
Contact:
619-303-6130

Viking Clinical Site #2051
Lincoln 5366375, California 5332921 95648
Contact:
916-487-8230

Viking Clinical Site #2050
Long Beach 5367929, California 5332921 90815
Contact:
562-997-1000

Viking Clinical Site #2055
Los Angeles 5368361, California 5332921 90057
Contact:
213-483-1800

Viking Clinical Site #2078
Manteca 5370164, California 5332921 95336
Contact:
209-918-3344

Viking Clinical Site #2053
Montclair 5374232, California 5332921 91763
Contact:
909-590-6305

Viking Clinical Site #2068
Panorama City 5380932, California 5332921 91402
Contact:
818-532-6880

Viking Clinical Site #2132
Rolling Hills Estates 5388601, California 5332921 90274
Contact:
310-265-1753

Viking Clinical Site #2131
San Diego 5391811, California 5332921 92103
Contact:
858-278-3647

Viking Clinical Site #2052
Spring Valley 5398277, California 5332921 91978
Contact:
619-660-9068

Viking Clinical Site #2109
Tustin 5404119, California 5332921 92780
Contact:
714-734-7944

Viking Clinical Site #2067
Van Nuys 5405693, California 5332921 91405
Contact:
818-855-8785

Viking Clinical Site #2079
Walnut Creek 5406990, California 5332921 94598
Contact:
925-930-7267

Viking Clinical Site #2119
Denver 5419384, Colorado 5417618 80210
Contact:
303-353-2660

Viking Clinical Site #2123
Washington D.C. 4140963, District of Columbia 4138106 20036
Contact:
202-293-1000

Viking Clinical Site #2013
Clearwater 4151316, Florida 4155751 33756
Contact:
727-584-6368

Viking Clinical Site #2121
Clearwater 4151316, Florida 4155751 33761
Contact:
727-724-3316

Viking Clinical Site #2003
Cooper City 4151824, Florida 4155751 33024
Contact:
754-263-2001

Viking Clinical Site #2112
DeLand 4152890, Florida 4155751 32720
Contact:
386-785-2400

Viking Clinical Site #2107
Delray Beach 4153132, Florida 4155751 33445
Contact:
561-374-8461

Viking Clinical Site #2083
Fort Myers 4155995, Florida 4155751 33912
Contact:
239-936-4421

Viking Clinical Site #2058
Jacksonville 4160021, Florida 4155751 32216
Contact:
904-730-0101

Viking Clinical Site #2076
Lakeland 4161438, Florida 4155751 33803
Contact:
863-940-2087

Viking Clinical Site #2060
Lakewood Rch 7255365, Florida 4155751 34211
Contact:
941-727-7772

Viking Clinical Site #2117
Miami 4164138, Florida 4155751 33122
Contact:
305-761-4482

Viking Clinical Site #2012
Ocoee 4166776, Florida 4155751 34761
Contact:
407-654-2724

Viking Clinical Site #2056
Palmetto Bay 4167634, Florida 4155751 33157
Contact:
305-300-2695

Viking Clinical Site #2011
Port Orange 4169156, Florida 4155751 32127
Contact:
363-304-7070

Viking Clinical Site #2057
West Palm Beach 4177887, Florida 4155751 33407
Contact:
561-251-4646

Viking Clinical Site #2116
Atlanta 4180439, Georgia 4197000 30329
Contact:
504-336-2667

Viking Clinical Site #2030
Columbus 4188985, Georgia 4197000 31904
Contact:
706-996-2921

Viking Clinical Site #2120
Rincon 4218882, Georgia 4197000 31326
Contact:
912-303-5983

Viking Clinical Site #2093
Savannah 4221552, Georgia 4197000 31406
Contact:
912-443-4253

Viking Clinical Site #2025
Woodstock 4231874, Georgia 4197000 30189
Contact:
678-494-5735

Viking Clinical Site #2062
Honolulu 5856195, Hawaii 5855797 96814
Contact:
808-440-4405

Viking Clinical Site #2080
Meridian 5600685, Idaho 5596512 83642
Contact:
208-377-8653

Viking Clinical Site #2006
Chicago 4887398, Illinois 4896861 60607
Contact:
312-431-6765

Viking Clinical Site #2146
Indianapolis 4259418, Indiana 4921868 46202
Contact:
504-383-8674

Viking Clinical Site #2127
Valparaiso 4927537, Indiana 4921868 46383
Contact:
219-464-8302

Viking Clinical Site #2147
Sioux City 4876523, Iowa 4862182 68776
Contact:
712-639-6300

Viking Clinical Site #2022
West Des Moines 4881346, Iowa 4862182 50266
Contact:
515-329-6800

Viking Clinical Site #2099
Wichita 4281730, Kansas 4273857 67207
Contact:
316-689-6635

Viking Clinical Site #2069
Lexington 4297983, Kentucky 6254925 40509
Contact:
859-977-7145

Viking Clinical Site #2040
Lexington 4297983, Kentucky 6254925 40513
Contact:
859-977-4005

Viking Clinical Site #2009
Louisville 4299276, Kentucky 6254925 40213
Contact:
502-214-3920

Viking Clinical Site #2118
Baton Rouge 4315588, Louisiana 4331987 70808
Contact:
225-763-2974

Viking Clinical Site #2139
Baton Rouge 4315588, Louisiana 4331987 70809
Contact:
225-900-7739

Viking Clinical Site #2106
Lafayette 4330145, Louisiana 4331987 70508
Contact:
337-451-0663

Viking Clinical Site #2020
Metairie 4333177, Louisiana 4331987 70006
Contact:
504-934-8092

Viking Clinical Site #2087
Monroe 4333669, Louisiana 4331987 71201
Contact:
318-716-3113

Viking Clinical Site #2094
Chevy Chase 4351335, Maryland 4361885 20815
Contact:
301-841-6869

Viking Clinical Site #2145
Rockville 4367175, Maryland 4361885 20850
Contact:
504-336-2667

Viking Clinical Site #2066
Rockville 4367175, Maryland 4361885 20854
Contact:
443-659-8685

Viking Clinical Site #2001
Methuen 4943828, Massachusetts 6254926 01844
Contact:
978-655-7155

Viking Clinical Site #2038
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
734-418-7736

Viking Clinical Site #2140
Gulfport 4428667, Mississippi 4436296 39503
Contact:
504-336-2667

Viking Clinical Site #2031
City of Saint Peters 4407237, Missouri 4398678 63303
Contact:
636-387-5100

Viking Clinical Site #2016
Kansas City 4393217, Missouri 4398678 64131
Contact:
816-361-0055

Viking Clinical Site #2125
Springfield 4409896, Missouri 4398678 65807
Contact:
417-883-7889

Viking Clinical Site #2010
Butte 5642934, Montana 5667009 59701
Contact:
406-723-1375

Viking Clinical Site #2075
Omaha 5074472, Nebraska 5073708 68134
Contact:
402-933-6500

Viking Clinical Site #2035
Las Vegas 5506956, Nevada 5509151 89148
Contact:
702-736-5161

Viking Clinical Site #2034
Reno 5511077, Nevada 5509151 89511
Contact:
877-557-3732

Viking Clinical Site #2065
Lebanon 5088597, New Hampshire 5090174 03756
Contact:
603-653-3337

Viking Clinical Site #2029
Albuquerque 5454711, New Mexico 5481136 87109
Contact:
505-938-3810

Viking Clinical Site #2088
Albany 5106834, New York 5128638 12205
Contact:
518-560-2562

Viking Clinical Site #2042
East Syracuse 5116079, New York 5128638 13057
Contact:
315-760-5905

Viking Clinical Site #2096
Hartsdale 5120141, New York 5128638 10530
Contact:
914-341-2346

Viking Clinical Site #2133
New York 5128581, New York 5128638 10036
Contact:
646-722-6214

Viking Clinical Site #2021
The Bronx 5110266, New York 5128638 10455
Contact:
347-270-1111

Viking Clinical Site #2032
Westfield 5144083, New York 5128638 14787
Contact:
716-326-4890

Viking Clinical Site #2141
Charlotte 4460243, North Carolina 4482348 28205
Contact:
504-336-2667

Viking Clinical Site #2101
Fayetteville 4466033, North Carolina 4482348 28304
Contact:
910-484-8163

Viking Clinical Site #2026
Greensboro 4469146, North Carolina 4482348 27410
Contact:
336-235-0991

Viking Clinical Site #2110
Morehead City 4480153, North Carolina 4482348 28557
Contact:
252-222-5700

Viking Clinical Site #2061
Morehead City 4480153, North Carolina 4482348 28857
Contact:
252-515-0050

Viking Clinical Site #2115
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
336-713-1411

Viking Clinical Site #2027
Fargo 5059163, North Dakota 5690763 58104
Contact:
701-232-7705

Viking Clinical Site #2043
Cincinnati 4508722, Ohio 5165418 45219
Contact:
513-769-2767

Viking Clinical Site #2074
Cincinnati 4508722, Ohio 5165418 45242
Contact:
513-769-2767

Viking Clinical Site #2044
Cleveland 5150529, Ohio 5165418 44122
Contact:
216-682-0320

Viking Clinical Site #2089
Columbus 4509177, Ohio 5165418 43215
Contact:
614-487-2560

Viking Clinical Site #2113
Norman 4543762, Oklahoma 4544379 73069
Contact:
405-701-8999

Viking Clinical Site #2137
Tulsa 4553433, Oklahoma 4544379 74133
Contact:
918-932-2276

Viking Clinical Site #2097
Portland 5746545, Oregon 5744337 97202
Contact:
503-238-6233

Viking Clinical Site #2126
Portland 5746545, Oregon 5744337 97210
Contact:
503-279-8252

Viking Clinical Site #2045
East Greenwich 5221875, Rhode Island 5224323 02818
Contact:
401-739-9350

Viking Clinical Site #2028
Greenville 4580543, South Carolina 4597040 29607
Contact:
864-334-0141

Viking Clinical Site #2134
Myrtle Beach 4588718, South Carolina 4597040 29572
Contact:
843-994-7655

Viking Clinical Site #2023
North Charleston 4589387, South Carolina 4597040 29405
Contact:
843-856-3784

Viking Clinical Site #2004
Knoxville 4634946, Tennessee 4662168 37909
Contact:
865-410-8300

Viking Clinical Site #2008
Nashville 4644585, Tennessee 4662168 37203
Contact:
615-329-0197

Viking Clinical Site #2047
Abilene 4669635, Texas 4736286 79606
Contact:
325-400-1150

Viking Clinical Site #2063
Austin 4671654, Texas 4736286 78131
Contact:
512-334-3505

Viking Clinical Site #2007
Austin 4671654, Texas 4736286 78705
Contact:
512-480-9660

Viking Clinical Site #2091
Bellaire 4673353, Texas 4736286 77401
Contact:
866-442-9422

Viking Clinical Site #2124
Brownsville 4676740, Texas 4736286 78526
Contact:
956-303-2776

Viking Clinical Site #2049
Dallas 4684888, Texas 4736286 75230
Contact:
(682) 348-1169

Viking Clinical Site #2048
Dallas 4684888, Texas 4736286 75235
Contact:
469-893-1242

Viking Clinical Site #2111
Frisco 4692559, Texas 4736286 75033
Contact:
972-354-1520

Viking Clinical Site #2046
Houston 4699066, Texas 4736286 77040
Contact:
713-779-5494

Viking Clinical Site #2077
Lampasas 4705176, Texas 4736286 76550
Contact:
512-556-4130

Viking Clinical Site #2143
San Antonio 4726206, Texas 4736286 78215
Contact:
210-253-3426

Viking Clinical Site #2085
San Antonio 4726206, Texas 4736286 78222
Contact:
210-368-6055

Viking Clinical Site #2015
San Antonio 4726206, Texas 4736286 78229
Contact:
210-949-0122

Viking Clinical Site #2102
Seabrook 4727596, Texas 4736286 77586
Contact:
832-457-2167

Viking Clinical Site #2002
Ogden 5779206, Utah 5549030 84405
Contact:
801-409-2040

Viking Clinical Site #2092
Salt Lake City 5780993, Utah 5549030 84107
Contact:
801-288-0607

Viking Clinical Site #2039
Sandy City 5781061, Utah 5549030 84094
Contact:
801-409-2040

Viking Clinical Site #2024
St. George 5546220, Utah 5549030 84790
Contact:
435-656-1704

Viking Clinical Site #2098
Arlington 4744709, Virginia 6254928 22205
Contact:
407-916-0060

Viking Clinical Site #2082
Suffolk 4788158, Virginia 6254928 23435
Contact:
757-538-7553

Viking Clinical Site #2072
Renton 5808189, Washington 5815135 98057
Contact:
425-970-1323

Viking Clinical Site #2041
Spokane 5811696, Washington 5815135 99218
Contact:
509-505-6227

Viking Clinical Site #2130
Mayagüez 4566385, Puerto Rico 00680
Contact:
787-722-1248

Viking Clinical Site #2086
San Juan 4568127, Puerto Rico 00927
Contact:
787-722-1248

More Details

Status
Recruiting
Sponsor
Viking Therapeutics, Inc.

Study Contact

Maris Johnson
Clinicaltrials@vikingtherapeutics.com