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Viking Therapeutics Announces Initiation of VK2735 Oral Phase 3 Clinical Program in Patients with Obesity

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  • Viking Therapeutics initiated the SUNRISE Phase 3 clinical program to evaluate oral VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity & type 2 diabetes.
  • The program comprises two randomized, double-blind, placebo-controlled trials: SUNRISE-1 for obese/overweight adults without diabetes & SUNRISE-2 for those with type 2 diabetes.
  • Each study targets enrollment of 560 adults who will receive once-daily oral VK2735 doses of 27.5 mg, 35 mg, 55 mg, or placebo for 68 weeks.
  • The primary endpoint for both trials is the percent change in body weight from baseline compared to placebo after 68 weeks of treatment.
  • Previous Phase 2 VENTURE-Oral results showed up to 12.2% mean body weight reduction at 13 weeks with no plateau, 97% of patients achieving ≥5% weight loss, & 80% achieving ≥10% weight loss.
  • Oral VK2735 demonstrated favorable safety in Phase 2, with 98% of drug-related adverse events classified as mild or moderate & gastrointestinal events subsiding with continued dosing.
  • Viking is also conducting a maintenance dosing trial for oral VK2735 & two Phase 3 subcutaneous studies (VANQUISH-1 & VANQUISH-2) evaluating weekly dosing in 4,500 & 1,000 patients respectively.
  • A correction was issued to clarify that the oral maintenance trial evaluates daily oral doses, monthly subcutaneous doses, or every-other-week subcutaneous doses rather than weekly oral doses.
  • VK2735 represents the most advanced oral dual GLP-1/GIP agonist in clinical development & aims to offer flexible dosing options for long-term obesity management.
  • The company also advances other programs including VK3019 (amylin agonist), VK2809 (thyroid hormone receptor beta agonist), & VK0214 (for X-ALD).