Viking Therapeutics has initiated a 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.
The Phase 2 VENTURE trial is a randomised, double-blind, placebo-controlled study that will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of four different doses of VK2735, administered subcutaneously, once weekly. The 13-week trial will enrol approximately 125 adults who are living with obesity (BMI ≥30 kg/m2) or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. The primary endpoint of the study is the percent change in body weight from baseline to Week 13, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures.
"We are excited to announce the initiation of the VENTURE study, which will build upon the promising VK2735 Phase 1 data we reported earlier this year," said Dr Brian Lian, chief executive officer of Viking. "Obesity is a major healthcare challenge, and recent data confirm that effective weight loss agents can reduce a patient's cardiovascular risk profile, providing important health benefits. We look forward to exploring VK2735's safety and weight loss efficacy over this study's 13-week dosing window."
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.
The majority of observed adverse events (98%) in the Phase 1 trial were reported as mild or moderate. The majority of GI-specific adverse events (99%) were also reported as mild or moderate. Notably, despite robust activation of the incretin receptor pathways, no hypoglycemia was reported. The company believes that the tolerability data from the Phase 1 study indicate that higher doses may be achieved with longer titration windows.
Viking is also conducting a Phase 1 trial of a novel oral formulation of VK2735, which it believes may significantly expand the market opportunity for the compound by offering patients the option between subcutaneous and oral dosages forms. The company expects to report initial data from the oral formulation Phase 1 study in the fourth quarter of 2023.