Viking Therapeutics announced top-line results from its Phase 2 VENTURE-Oral Dosing trial of the oral tablet formulation of VK2735 on August 19, 2025. The study successfully achieved its primary and secondary endpoints, demonstrating statistically significant reductions in mean body weight up to 12.2% from baseline after 13 weeks of once-daily dosing. Participants achieved up to 10.9% placebo-adjusted mean weight loss, with up to 80% achieving at least 10% weight loss.
Despite the positive efficacy, the trial reported higher discontinuation rates due to adverse events among VK2735-treated subjects, at 20% compared to 13% for placebo. The overall treatment discontinuation rate was 28% for VK2735 subjects versus 18% for placebo. The most common reasons for discontinuation were gastrointestinal (GI)-related adverse events.
Specifically, nausea was reported in 58% of VK2735 participants compared with 48% for placebo, and vomiting was reported in 26% of VK2735-treated subjects compared with 10% for placebo. While the majority of GI adverse events were mild or moderate and generally observed early in treatment, these rates were higher than those seen in some competitor trials, raising investor concerns about the drug's tolerability profile.
An exploratory dosing cohort demonstrated that weight loss was maintained after transitioning from higher daily doses to a lower 30 mg daily dose, suggesting potential for maintenance therapy. However, the overall mixed safety and tolerability profile, particularly the discontinuation rates, led to a significant negative market reaction, with shares falling more than 30%.
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