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Viking Therapeutics (VKTX) investor relations material
Viking Therapeutics Bernstein Insights: Healthcare Leaders and Disruptors - 2nd Annual Healthcare Forum summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline and clinical development
Lead compound VK2735, a dual GLP-1/GIP agonist, is in Phase 3 for obesity with both subcutaneous and oral formulations advancing in trials.
Oral VK2735 achieved up to 12% weight loss in Phase 2, with strong dose response and promising maintenance data.
Subcutaneous VK2735 showed nearly 15% weight loss in Phase 2, with over 90% of efficacy maintained at week 17.
Amylin agonist program is expected to enter clinical trials late this year or early next year.
Additional thyroid beta receptor programs are available for licensing but not prioritized for near-term focus.
Safety, tolerability, and dosing strategy
Both oral and subcutaneous VK2735 demonstrated favorable safety profiles, with most adverse events mild to moderate and transient.
GI adverse events were most common early in titration and resolved quickly; slower titration is expected to further improve tolerability.
Maintenance regimens at lower doses are supported by data, showing continued or sustained weight loss.
Future studies will focus on optimized titration and maintenance strategies to balance efficacy and tolerability.
Regulatory and trial design considerations
Phase 3 trials are placebo-controlled as required by current regulatory guidance, with active comparators considered for future studies.
BMI inclusion criteria for Phase 3 allow for 30+ or 27+ with comorbidities, aligning with industry standards.
End-of-Phase 2 FDA meeting for the oral program is planned for Q4 to determine next steps toward Phase 3.
No regulatory path exists for maintenance-only approval; all studies are designed for weight change endpoints.
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