Viking Therapeutics announces the initiation of the VANQUISH Phase 3 clinical program for VK2735, the company's dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptid receeptors (26.95)
- VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of metabolic disorders such as obesity.
- The VANQUISH Phase 3 program includes two studies evaluating VK2735: one in adults with obesity and one in obese or overweight adults with type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study will target enrollment of approximately 4500 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. The VANQUISH-2 study will target enrollment of approximately 1100 adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomized to one of four weekly treatment arms: VK2735 7.5 mg, VK2735 12.5 mg, VK2735 17.5 mg, and placebo.
- The primary endpoint of the trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve =5%, =10%, =15% and =20% body weight reduction. Each study will include an open-label extension allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.