Viking Therapeutics starts Phase 3 trials of oral VK2735 for obesity
Viking Therapeutics has begun two Phase 3 trials of oral VK2735, a once-daily dual GLP-1/GIP pill, targeting 560 adults in each study.
Viking Therapeutics said on October 14, 2026 that it has started the SUNRISE Phase 3 program for oral VK2735, a once-daily tablet form of its dual GLP-1/GIP receptor agonist, in adults with obesity and in adults with type 2 diabetes [1].
The program has two randomized, double-blind, placebo-controlled, multicenter trials. SUNRISE-1 will enroll adults with a BMI of 30 kg/m2 or higher, or a BMI of 27 kg/m2 or higher plus at least one weight-related health condition, who do not have type 2 diabetes. SUNRISE-2 will enroll adults with type 2 diabetes who are obese or overweight [1]. Each trial targets 560 participants, assigned to one of four groups: once-daily oral VK2735 at 27.5 mg, 35 mg, or 55 mg, or placebo, for 68 weeks [1]. The program is listed in the federal registry ClinicalTrials.gov under the identifier NCT07868835 [2].
The main measure in both trials is the percent change in body weight from the start of the study for people taking oral VK2735 compared with placebo after 68 weeks. Secondary and exploratory measures include the share of patients who lose at least 5%, 10%, 15% or 20% of their body weight [1].
Viking reported in 2025 that its Phase 2 VENTURE-Oral Dosing trial of the tablet met its primary and secondary endpoints. After 13 weeks, patients taking once-daily oral VK2735 had dose-dependent average weight reductions from baseline of up to 12.2%; differences from placebo were statistically significant for all doses above 15 mg starting at week 1 and held through the study. Weight loss continued through week 13 with no evidence of a plateau. Up to 97% of patients on VK2735 lost at least 5% of body weight and up to 80% lost at least 10%, compared with 10% and 5% of those on placebo [1].
On safety, Viking said 98% of reported drug-related treatment-emergent adverse events in that Phase 2 trial were mild or moderate. Gastrointestinal events were the most common and consistent with the known effects of dual GLP-1/GIP receptor agonists; they generally occurred early in treatment and subsided with continued dosing [1].
Viking is also testing an injected form of VK2735. Two Phase 3 trials, VANQUISH-1 and VANQUISH-2, are fully enrolled — about 4,500 adults without type 2 diabetes and about 1,000 adults with type 2 diabetes, respectively — using weekly subcutaneous doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo for 78 weeks [1]. A separate maintenance-dosing trial of oral VK2735 is under way; Viking also issued a correction on October 14, 2026 stating that an October 6, 2026 release about that trial wrongly described "weekly oral doses." That trial is evaluating maintenance options including daily oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo [1].
Why it matters for patients
The obesity medicines now on the US market belong to two groups. Semaglutide is marketed as Ozempic, Rybelsus and Wegovy, and tirzepatide as Mounjaro and Zepbound [1]. Oral VK2735 is investigational; no approval for it has been announced [1]. A daily pill could add a choice of format for people who prefer not to inject, though whether it would match the weight loss seen with injected drugs at 68 weeks is not yet known.
Viking chief executive Brian Lian said obesity is a chronic disease that often requires long-term treatment, making convenience and ease of use important, and that a once-daily oral therapy "could offer a flexible dosing option that may support improved treatment adherence over time" [1]. That is the company's expectation, not a trial result. VK2735 has not been compared head-to-head with semaglutide or tirzepatide in the studies described [1], and no trial has reported whether it reduces heart attacks, strokes or other health outcomes.
What happens next
Both SUNRISE trials aim to enroll 560 adults each and run 68 weeks of treatment [1]. The announcement did not disclose when the trials would finish enrolling, when they would be completed, or when results would be reported [1]. The subcutaneous VANQUISH-1 and VANQUISH-2 trials are already fully enrolled, and Viking has not said when their results are expected [1].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.