Viking Therapeutics announced the initiation of a phase 2 clinical trial of the oral tablet formulation of its dual GLP-1/GIP receptor agonist, VK2735, being studied in various metabolic conditions, such as obesity.
The phase 2 VENTURE-Oral Dosing Trial is a placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial will enroll approximately 280 adults who are obese or overweight with at least one weight-related co-morbid condition.
The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.
Viking previously reported positive results from a phase 1 multiple ascending dose (MAD) clinical trial of VK2735 tablets in healthy volunteers with a BMI ≥30. Participants experienced up to 6.8% placebo-adjusted mean weight loss (8.2% weight loss from baseline) after 28 days of dosing with the oral tablet.
Concurrent with the development of oral VK2735, Viking is also advancing a subcutaneous formulation of VK2735 through clinical development.