Viking Therapeutics Announces Positive Top-Line Results for VK2735 Obesity Trial.

Viking Therapeutics announced positive top-line results from its Phase 2 VENTURE-Oral trial of VK2735, a tablet formulation for obesity treatment. The study achieved primary and secondary endpoints, demonstrating statistically significant reductions in body weight with once-daily VK2735 dosing compared to placebo. Up to 12.2% (26.6 lbs) mean weight loss was observed after 13 weeks of VK2735 treatment, while placebo showed a 1.3% (2.9 lbs) weight loss. VK2735 was shown to be safe and well-tolerated, with 99% of GI-specific treatment emergent adverse events considered mild or moderate.

Viking Therapeutics, Inc. (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders, has announced positive top-line results from its Phase 2 VENTURE-Oral trial of VK2735. The study, which evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks, achieved its primary and secondary endpoints.

The trial demonstrated statistically significant reductions in body weight with once-daily VK2735 dosing compared to placebo. Participants receiving VK2735 showed up to 12.2% (26.6 lbs) mean weight loss after 13 weeks, compared to 1.3% (2.9 lbs) for placebo [1]. The study also showed VK2735 to be safe and well-tolerated, with 99% of gastrointestinal (GI)-specific treatment emergent adverse events considered mild or moderate [1].

VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. The study included an exploratory dosing cohort designed to assess weight loss maintenance, which showed rapid and progressive weight loss through the 90 mg treatment period and maintained weight loss following the transition to 30 mg daily doses [1].

Brian Lian, Ph.D., chief executive officer of Viking, commented, "We are excited to report the top-line Phase 2 study results for the once-daily oral tablet of VK2735. As in prior studies, we observed a clear dose response and impressive weight loss across the 13-week treatment period. The progressive nature of the weight loss curves suggests the potential for further improvement with longer dosing periods. The experimental maintenance arm of this study provides an encouraging signal that supports our belief that transitioning patients from higher doses, injectable or oral, to low oral doses represents a promising approach to weight maintenance therapy. We look forward to exploring this further in an upcoming maintenance dosing study."

The Phase 2 VENTURE-Oral Dosing Trial was a randomized, double-blind, placebo-controlled multicenter study that enrolled 280 adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition [1].

References:
[1] https://www.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-oral-dosing-trial-of-vk2735-tablet-formulation-in-patients-with-obesity-302533355.html