Viking Starts Phase 3 SUNRISE Program for Oral VK2735 in Obesity

Viking Therapeutics has started the SUNRISE Phase 3 clinical program for an oral tablet formulation of VK2735, the company announced on October 14, 2026.¹ VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. The program includes two studies: SUNRISE-1 in adults with obesity, and SUNRISE-2 in adults with obesity or overweight and type 2 diabetes.¹

What is the SUNRISE program evaluating?

Both SUNRISE studies are randomized, double-blind, placebo-controlled, multicenter trials. Patients will take oral VK2735 once daily for 68 weeks, and each study will aim to enroll 560 adults.¹

• SUNRISE-1 will enroll adults without type 2 diabetes who have obesity (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity.
• SUNRISE-2 will enroll adults with type 2 diabetes who have obesity or overweight.

Participants in both trials will be randomized to once-daily doses of 27.5 mg, 35 mg, or 55 mg of VK2735, or to placebo.¹

The primary endpoint of both trials is the percent change in body weight from baseline after 68 weeks, compared with placebo. Secondary and exploratory endpoints include the share of patients who lose at least 5%, 10%, 15%, or 20% of their baseline body weight.¹

“Oral VK2735 represents the most advanced oral dual GLP-1/GIP agonist in clinical development and has the potential to be positioned as either an induction therapy or in the maintenance setting, increasing the treatment options available to patients and clinicians,” said Brian Lian, PhD, chief executive officer of Viking.¹

How does dual GLP-1/GIP agonism work?

According to Viking, activating the GLP-1 receptor has been shown to lower glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both.¹ Researchers have explored co-activating the GIP receptor as a way to enhance those benefits. The FDA has already approved one dual GLP-1/GIP receptor agonist, tirzepatide, marketed as Mounjaro and Zepbound.¹

In December 2025, the FDA approved oral semaglutide 25 mg, marketed as the Wegovy pill, as the first oral GLP-1 for lowering body weight.² In the US, 40.3% of adults had obesity between August 2021 and August 2023, according to the CDC.³

What did phase 2 data show?

Viking reported results from the Phase 2 VENTURE-Oral Dosing study in 2025. After 13 weeks, patients taking oral VK2735 once daily lost up to 12.2% of their baseline body weight on average. The reductions were statistically significant and increased with dose.¹ All doses above 15 mg separated significantly from placebo starting at week 1. Weight loss continued through week 13 with no sign of a plateau.¹

• Up to 97% of patients on oral VK2735 lost at least 5% of their body weight, compared with 10% on placebo.
• Up to 80% lost at least 10%, compared with 5% on placebo.¹

Of the drug-related treatment-emergent adverse events reported, 98% were mild or moderate. Gastrointestinal events were the most common. They generally occurred early in treatment and subsided with continued dosing.¹

Viking has described once-daily oral dosing as a flexible option that may support better treatment adherence over time.¹ Speaking about a different chronic disease, Juby Jacob-Nara, MD, senior vice president and chief medical officer of Celltrion USA, described what long-term treatment requires in a 2026 interview with BioPharm International. “Number one, the product has to work and the patients have to get it and the drug has to stay consistent to sustain the efficacy,” she said.

What else is Viking developing?

Viking is also running a maintenance dosing trial of oral VK2735. It has two phase 3 studies of subcutaneous VK2735, VANQUISH-1 and VANQUISH-2, which test weekly dosing for 78 weeks. Both are fully enrolled, with about 4,500 and 1,000 adults, respectively.¹ The company’s obesity pipeline also includes VK3019, an amylin receptor agonist.¹

References

1. Viking Therapeutics. Viking Therapeutics announces initiation of VK2735 oral Phase 3 clinical program in patients with obesity. Press release. Published October 14, 2026. Accessed October 14, 2026.
2. Healio. FDA approves Wegovy pill, the first oral GLP-1 to treat obesity. Published December 23, 2025. Accessed October 14, 2026.
3. Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and severe obesity prevalence in adults: United States, August 2021–August 2023. NCHS Data Brief No. 508. Published September 24, 2024. Accessed October 14, 2026.