Viking completes enrolment in VANQUISH-1 Trial of VK2735

Viking Therapeutics has completed patient enrolment in its Phase 3 VANQUISH-1 clinical trial of subcutaneous VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of metabolic disorders such as obesity.

The Phase 3 VANQUISH-1 study is a randomised, double-blind, placebo-controlled, multi-centre trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The trial enrolled approximately 4,650 adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Enrolled patients have been randomized to one of four weekly treatment arms: VK2735 7.5 mg, 12.5 mg, 17.5 mg, and placebo.

The primary endpoint of the trial 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 are evaluating a range of additional safety and efficacy measures, including the percentage of patients who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction. The study includes a 52-week extension period allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

Concurrently, Viking is conducting the Phase 3 VANQUISH-2 study of subcutaneous VK2735 in patients with type 2 diabetes who have obesity or are overweight. That trial is currently enrolling patients, and the company expects to complete enrolment in the first quarter of 2026.

In 2024, Viking announced positive results from the Phase 2 VENTURE study of VK2735 in obesity. This trial successfully achieved its primary and secondary endpoints, with subjects receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo.

After 13 weekly subcutaneous doses, subjects receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% with no signs of plateau. VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events (AEs) being reported as mild or moderate. Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo.