This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. VK2735 or matched placebo will be administered once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
Viking Clinical Site #111
Peoria, Arizona, United States
Viking Clinical Site #105
Lake Forest, California, United States
Viking Clinical Site #101
Percent (relative) change from baseline in body weight after 13 weeks of treatment
To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
Time frame: 13 Weeks
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment
To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
Time frame: 13 Weeks
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Clearwater, Florida, United States
Viking Clinical Site #108
Largo, Florida, United States
Viking Clinical Site #107
Ocoee, Florida, United States
Viking Clinical Site #102
Port Orange, Florida, United States
Viking Clinical Site #100
Indianapolis, Indiana, United States
Viking Clinical Site #110
Louisville, Kentucky, United States
Viking Clinical Site #114
Marrero, Louisiana, United States
Viking Clinical Site #109
City of Saint Peters, Missouri, United States
...and 5 more locations