VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) (NCT07104383)
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (13 items).
Location: Viking Clinical Site #2037 โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (127 Sites)
- Viking Clinical Site #2037 โ Birmingham, Alabama
- Viking Clinical Site #2064 โ Birmingham, Alabama
- Viking Clinical Site #2128 โ Huntsville, Alabama
- Viking Clinical Site #2005 โ Chandler, Arizona
- Viking Clinical Site #2017 โ Flagstaff, Arizona
- Viking Clinical Site #2018 โ Peoria, Arizona
- Viking Clinical Site #2135 โ Scottsdale, Arizona
- Viking Clinical Site #2019 โ Tucson, Arizona
- Viking Clinical Site #2036 โ Little Rock, Arkansas
- Viking Clinical Site #2071 โ Chula Vista, California
- Viking Clinical Site #2070 โ Escondido, California
- Viking Clinical Site #2054 โ Huntington Park, California
- Viking Clinical Site #2014 โ Lake Forest, California
- Viking Clinical Site #2129 โ Lemon Grove, California
- Viking Clinical Site #2051 โ Lincoln, California
- Viking Clinical Site #2050 โ Long Beach, California
- Viking Clinical Site #2078 โ Manteca, California
- Viking Clinical Site #2053 โ Montclair, California
- Viking Clinical Site #2068 โ Panorama City, California
- Viking Clinical Site #2132 โ Rolling Hills Estates, California
- Viking Clinical Site #2131 โ San Diego, California
- Viking Clinical Site #2052 โ Spring Valley, California
- Viking Clinical Site #2109 โ Tustin, California
- Viking Clinical Site #2067 โ Van Nuys, California
- Viking Clinical Site #2079 โ Walnut Creek, California
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.