Viking launches Phase 3 oral obesity trials

• Viking Therapeutics (NASDAQ:VKTX) initiated its SUNRISE Phase 3 clinical program evaluating oral VK2735 as a potential treatment for obesity.
• The program includes two placebo-controlled studies designed to evaluate once-daily oral VK2735 over 68 weeks in adults with and without type 2 diabetes.
• The Phase 3 launch follows positive Phase 2 VENTURE-Oral results showing mean body weight reductions of up to 12.2% after 13 weeks.

Viking Therapeutics (NASDAQ:VKTX) announced the start of its SUNRISE Phase 3 clinical program for oral VK2735, an investigational therapy being developed for obesity management.

The program consists of two studies: SUNRISE-1, enrolling approximately 560 adults without type 2 diabetes, and SUNRISE-2, enrolling approximately 560 adults with type 2 diabetes.

Both trials are placebo-controlled studies evaluating once-daily VK2735 treatment over 68 weeks.

The primary endpoint will measure the percentage change in body weight from baseline.

The Phase 3 program follows results from the Phase 2 VENTURE-Oral study, which met its primary and secondary endpoints.

In the Phase 2 study, mean body weight reductions reached up to 12.2% after 13 weeks of treatment.

Viking reported that 98% of drug-related adverse events occurring during treatment were mild or moderate, with gastrointestinal events representing the most frequently reported side effects.

Viking is also evaluating oral VK2735 in a maintenance dosing study.

In addition to its oral program, the company’s injectable VK2735 Phase 3 VANQUISH-1 and VANQUISH-2 studies are fully enrolled.

VANQUISH-1 includes approximately 4,500 adults, while VANQUISH-2 includes approximately 1,000 adults, with both trials evaluating weekly treatment over 78 weeks.

Viking Therapeutics develops therapies targeting metabolic and endocrine disorders, including obesity and related conditions.