Viking Therapeutics Advances VK2735 Obesity Drug Into Phase 3 After 15% Weight Loss

Viking Therapeutics has advanced VK2735 into Phase 3 after the GLP-1/GIP drug produced 14.7% weight loss over 13 weeks at the highest Phase 2 dose. Two weekly injectable trials are fully enrolled, with results expected in the second half of 2027. The company plans to begin Phase 3 trials of an oral VK2735 tablet in the fourth quarter, though the program is expected to trail the injectable version by 12 to 18 months. Viking is also studying whether less frequent dosing can maintain weight loss while limiting gastrointestinal side effects. Viking is building substantial manufacturing capacity and preparing for potential independent commercialization, while remaining open to partnerships. Its additional pipeline includes VK3019, a long-acting amylin agonist that showed greater weight loss than VK2735 in obese monkeys. Viking Therapeutics NASDAQ: VKTX said its obesity drug candidate VK2735 has advanced into Phase 3 development following Phase 2 results that showed approximately 15% weight loss from baseline after 13 weeks at the highest tested dose. Speaking at the Morgan Stanley Global Healthcare Conference, President and CEO Brian Lian said the company has fully enrolled two Phase 3 trials of weekly subcutaneous VK2735: VANQUISH-1 in patients with obesity and VANQUISH-2 in patients with obesity and type 2 diabetes. Viking expects both studies to report data in the second half of 2027. The company is also developing an oral tablet formulation of the same GLP-1/GIP dual agonist. Lian said Viking plans to begin two Phase 3 studies of the oral formulation in the fourth quarter. The oral program is expected to trail the injectable program by roughly 12 to 18 months. Multiple Formulations and Maintenance Dosing Lian said Viking’s strategy is to offer patients options across injectable and oral formulations, potentially allowing patients to transition between the products without introducing a new molecule or a substantially different adverse-event profile. The company is also conducting a maintenance study designed to determine whether patients can maintain weight loss after transitioning from weekly dosing to every-other-week or monthly dosing. Viking has guided to data from that study during the current quarter. The maintenance study evaluates every-other-week doses of 5 milligrams, 7.5 milligrams and 10 milligrams, as well as monthly doses up to 22.5 milligrams. It also includes an arm that continues weekly 17.5-milligram dosing through 33 weeks. Lian said the company will focus on several measures in the results, including weight-loss trends following the transition to less frequent dosing, tolerability during the maintenance period, and the proportion of initial weight loss maintained. He said Viking would likely report results from the 17.5-milligram weekly arm, while noting that the group includes 15 patients. He said a key unanswered question is whether less frequent administration could reinitiate gastrointestinal side effects such as nausea, vomiting, constipation and diarrhea. Viking would view tolerability during the maintenance period as particularly important, he said, because favorable tolerability could support testing higher doses. Phase 3 Design and Oral Program In Phase 2, VK2735 was tested at doses up to 15 milligrams weekly, producing 14.7% weight loss from baseline after 13 weeks, according to Lian. The ongoing Phase 3 injectable studies will test doses up to 17.5 milligrams over 78 wee...