13-Week Study to Evaluate the Safety and Efficacy of VK2735 Dosed Weekly
Trial Size Increased from 125 to 176 Patients Due to Elevated Demand
SAN DIEGO, Oct. 23, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of patient enrollment 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 randomized, 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 enroll 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 enrollment 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 enroll the study more rapidly than anticipated, but to significantly exceed our original enrollment 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 Brian Lian, Ph.D., chief executive officer of Viking. "We look forward to reporting the results from this important study in the first half of 2024."
Viking previously reported positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 in healthy volunteers with a BMI ≥30. In the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. In the 28-day MAD portion of the study, VK2735 was well-tolerated and showed positive signs of clinical activity. All MAD cohorts receiving VK2735 experienced reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered.
These results were featured earlier this month in an oral presentation at ObesityWeek® 2023, the annual meeting of the Obesity Society. The presentation highlighted the previously-reported safety, tolerability, and weight loss findings, as well as new data demonstrating VK2735's impact on liver fat and plasma lipids. Notably, after four weekly doses of VK2735, subjects in the Phase 1 trial reported liver fat reductions of up to 47% from baseline (placebo-adjusted, p