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 positive top-line results from the company's Phase 2 clinical trial of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders such as obesity. The Phase 2 VENTURE trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. Additionally, the study showed VK2735 treatment to be safe and well tolerated with the majority of treatment emergent adverse events (TEAEs) being categorized as mild or moderate. Based on these findings, Viking intends to meet with the FDA and discuss next steps in the development of VK2735.

Top-line study results include:

Body Weight Reductions

Patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%. Statistically significant differences compared to both baseline and placebo were observed for all doses starting at Week one and continuing throughout the 13-week treatment period. Reductions in body weight were progressive through the course of the study, with no plateau observed for weight loss at 13 weeks. All doses of VK2735 also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of patients demonstrating at least 10% weight loss. Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo.

Observed Change in Body Weight Following 13 Weeks of Once-Weekly Dosing with VK2735

Safety and Tolerability

VK2735 demonstrated encouraging safety and tolerability following 13 weeks of once-weekly dosing. Discontinuation rates in the VENTURE study were low and well-balanced among patients treated with VK2735 compared with placebo. A total of 23 patients (13%) discontinued treatment in the study, 5 (14%) in the placebo cohort and 18 (13%) among VK2735-treated cohorts.

Among patients receiving VK2735, the majority (92%) reported drug related TEAEs as mild or moderate in severity. The majority of TEAEs that were gastrointestinal (GI) in nature (95%) were also reported as mild or moderate. Nausea was reported among patients receiving both VK2735 (43%) and placebo (20%). Among subjects receiving VK2735, the majority of reported nausea (68%) was characterized as mild (32% moderate, none severe). Vomiting was reported in 25/140 (18%) VK2735-treated patients compared with none reported among patients receiving placebo. GI-related adverse events were generally observed early in treatment, with decreasing frequency upon repeat dosing. Across the combined VENTURE study arms, the weekly rate of nausea did not exceed 5% at any point after the first week of treatment. One patient receiving VK2735 experienced a serious adverse event (SAE) of dehydration that was characterized as related to study drug.

Discontinuation Rates and Common Gastrointestinal TEAEs Following 13 Weeks of Once-Weekly Dosing with VK2735

"We are excited to report the top-line results from this important Phase 2 study. VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects," said Brian Lian, Ph.D., chief executive officer of Viking. "Notably, robust weight loss compared with placebo was observed early across all doses evaluated in the VENTURE study, and continued throughout the treatment period in all treatment groups. No evidence of a plateau was observed at Week 13 for any VK2735 dose, suggesting further weight loss might be achieved from extended dosing periods. We look forward to progressing this important therapy into further clinical development later this year. Separately, we remain on track to report data from a Phase 1 study of an oral formulation of VK2735 later this quarter."

The Phase 2 VENTURE trial was 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 enrolled 176 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. The primary endpoint of the study was the assessment of the percent change in body weight from baseline to Week 13 among patients treated with VK2735 as compared with placebo, while secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures.

Conference Call

Management will host a conference call to discuss top-line results from the company's Phase 2 VENTURE trial today at 8:00 am Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until March 5, 2024, by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 6165205. Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at http://ir.vikingtherapeutics.com/webcasts. An archive of the webcast will also be available on the Webcasts page of Viking's website for 30 days.