Viking Therapeutics announced the initiation of a Phase 2 clinical trial for its oral tablet formulation of VK2735 on January 8, 2025. This study, named the VENTURE-Oral Dosing Trial, is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed once daily for 13 weeks.
The trial plans to enroll approximately 280 adults who are obese or overweight with at least one weight-related co-morbid condition. Participants will be evenly randomized across six dosing arms or placebo, with the primary endpoint being the percent change in body weight from baseline after 13 weeks of treatment. This advancement follows promising 28-day Phase 1 data that showed encouraging tolerability and dose-dependent reductions in mean body weight up to 8.2%.
The initiation of this Phase 2 study represents an important milestone for the VK2735 program, as Viking advances two formulations of this compound into later-stage development. The company believes VK2735's clinical results to date suggest a differentiated profile, offering patients and clinicians the flexibility of both subcutaneous injection and oral tablet formulations using the same active pharmaceutical ingredient.
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