Viking Therapeutics (VKTX) has initiated its SUNRISE Phase 3 clinical program to evaluate oral VK2735 for obesity. SUNRISE-1 and SUNRISE-2 each target 560 adults, without and with type 2 diabetes, respectively. The placebo-controlled trials will assess once-daily treatment over 68 weeks, with percent change in body weight from baseline as the primary endpoint.
The Phase 2 VENTURE-Oral study achieved its primary and secondary endpoints. Mean body weight reductions reached up to 12.2% after 13 weeks; 98% of reported drug-related adverse events arising during treatment were mild or moderate. Gastrointestinal events were the most common. Viking is also conducting an oral maintenance dosing trial. Its injectable Phase 3 VANQUISH-1 and VANQUISH-2 studies are fully enrolled, with approximately 4,500 and 1,000 adults, respectively, evaluating weekly treatment over 78 weeks.