#United States #San Diego #Viking Therapeutics #obesity #VK2735

Viking Therapeutics Completes Enrollment in VK2735 Phase 2 Trial

Viking Therapeutics, Inc., a biopharmaceutical company dedicated to developing innovative therapies for metabolic and endocrine disorders, has reached a significant milestone by completing patient enrollment for its Phase 2 VENTURE-Oral dosing trial of VK2735. This oral formulation targets individuals suffering from obesity, a condition affecting millions globally.

VK2735 operates as a dual agonist, impacting both glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. The trial's design is robust, featuring a randomized, double-blind, placebo-controlled multicenter approach that ensures comprehensive evaluation of the drug’s safety and efficacy.

Trial Overview

The VENTURE-Oral trial aims to assess the safety, tolerability, pharmacokinetics, and effectiveness of VK2735 when administered as an oral tablet once daily for 13 weeks. Approximately 280 adult participants, categorized as either obese ( BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m² with at least one weight-related condition), have been enlisted. Participants are randomized across six dosing arms or assigned to a placebo group.

The primary goal of the trial is to measure the percent change in body weight from the baseline after 13 weeks. Beyond this primary endpoint, additional safety and efficacy measures will also be evaluated. CEO Brian Lian, Ph.D., remarked on the high interest in participation, showcasing the urgency and need for effective treatments in combating obesity.

Historical Data and Safety Profile

Viking Therapeutics previously conducted a Phase 1 clinical trial involving the same VK2735 tablet formulation, which yielded promising results. Participants demonstrated dose-dependent weight reductions, achieving significant mean weight loss of up to 8.2% from baseline within just 28 days. This reduction persisted even at follow-up, suggesting ongoing efficacy beyond active treatment weeks.

The safety profile observed during these studies is reassuring, with nearly all treatment-emergent side effects being categorized as mild to moderate. Gastrointestinal events were prevalent but also mostly mild in nature, suggesting an overall favorable tolerability.

Future Expectations

Viking is not only focused on the oral formulation of VK2735; it is concurrently advancing a subcutaneous version through its clinical pipeline. Preliminary results from the VENTURE study of the subcutaneous formulation showed statistically significant weight loss results, sustaining across all treatment cohorts throughout the trial.

Looking forward, Viking Therapeutics aims to unveil results from the VENTURE-Oral trial in the latter half of 2025. This outcome holds immense potential not only for patients struggling with weight management but also for the broader landscape of obesity therapies.

The multi-faceted approach from Viking, including ongoing advancements in both oral and subcutaneous formulations, indicates a promising horizon for treating obesity and related metabolic disorders.

Conclusion

Viking Therapeutics' commitment to addressing serious metabolic issues stands out as a beacon of hope. As they continue to navigate through their research and clinical trials, the path towards effective treatment options for obesity becomes increasingly visible, marking a vital step in the biopharmaceutical industry’s fight against this pervasive health issue.