Viking Therapeutics Initiates SUNRISE Phase 3 Clinical Program For Oral VK2735 Dual Agonist Of GLP-1 And Glucose-Dependent Insulinotropic Polypeptide Receptors

VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

The SUNRISE Phase 3 program includes two studies evaluating oral VK2735: one in adults with obesity and another 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, with patients receiving once-daily oral VK2735 for 68 weeks. SUNRISE-1 and SUNRISE-2 will each target enrollment of 560 adults. SUNRISE-1 will include obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) adults without type 2 diabetes who have at least one weight-related comorbidity. SUNRISE-2 will enroll adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomly assigned to one of four treatment groups receiving once-daily VK2735 doses of 27.5 mg, 35 mg, 55 mg, or placebo.

The primary endpoint of both trials is the percent change in body weight from baseline for participants receiving oral VK2735 as compared to placebo after 68 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy metrics, including the percentage of patients who achieve ≥ 5%, ≥ 10%, ≥ 15% or ≥ 20% body weight reduction from baseline.