Viking Therapeutics Starts Phase 3 SUNRISE Trials of Oral Obesity Pill VK2735

VKTX announced on October 14 that it has started SUNRISE, the Phase 3 program for the oral version of VK2735, its dual GLP-1/GIP agonist for obesity (Viking release). SUNRISE-1 enrolls adults with obesity or overweight without type 2 diabetes, and SUNRISE-2 adults with type 2 diabetes; each targets about 560 patients, around 1,120 in total. Both test once-daily oral doses of 27.5 mg, 35 mg and 55 mg against placebo over 68 weeks, with percent change in body weight as the primary endpoint.

The program builds on Phase 2 data showing mean weight loss of up to 12.2% after 13 weeks, with up to 97% of patients losing at least 5% of body weight, per the company. "Oral VK2735 represents the most advanced oral dual GLP-1/GIP agonist in clinical development," CEO Brian Lian said. The injectable form is further along: its VANQUISH-1 and VANQUISH-2 Phase 3 trials, with about 4,500 and 1,000 adults, are fully enrolled.

The trials are funded in part by offerings priced in September: 7,857,143 shares at $35.00 and $225 million of 2.00% convertible notes due 2032, or $500 million before over-allotment options. The Motley Fool puts gross proceeds at $575 million including those options, while Stocktwits cited about $548 million. Viking held $502 million in cash and short-term investments at June 30, and its CFO said in July that cash would last into 2028.

Viking enters a crowded oral race: Eli Lilly (LLY) launched Foundayo in April and Novo Nordisk (NVO) introduced an oral Wegovy this year. VKTX shares were down 24% for the year as of the Phase 3 announcement and closed at $25.17 on October 16, well below the $35.00 offering price. Viking has not given readout timing; The Motley Fool's author expects SUNRISE results likely in 2028.