Viking Therapeutics has completed patient enrolment in its Phase 2 clinical trial of VK2735, the company's wholly-owned dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2735 is in development for the potential treatment of various metabolic disorders such as obesity. Viking expects to report data from the study in the first half of 2024.
The Phase 2 VENTURE trial is a randomised, double-blind, placebo-controlled study intended to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly. The 13-week trial was designed to enrol approximately 125 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition. Due to heightened clinician and patient interest, the trial's enrolment size was increased to 176 from the original target.
The primary endpoint of the study will assess the percent change in body weight from baseline to Week 13 among patients treated with VK2735 as compared with placebo, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures. The VENTURE trial will evaluate weekly VK2735 doses of up to 15 mg, compared to the 10 mg top dose evaluated in the prior Phase 1 multiple ascending dose (MAD) study.
"The high level of interest in this trial allowed us to not only enrol the study more rapidly than anticipated, but to significantly exceed our original enrolment target. This speaks both to the continued unmet needs of patients with obesity, and the promise demonstrated by the encouraging Phase 1 study data from VK2735 reported earlier this year," said Dr Brian Lian, chief executive officer of Viking. "We look forward to reporting the results from this important study in the first half of 2024."