Clinical Program Overview

Viking Therapeutics announced the initiation of the VANQUISH Phase 3 clinical development program for VK2735, a novel dual agonist targeting glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. The program comprises two large-scale, randomized, double-blind, placebo-controlled, multicenter trials designed to evaluate the efficacy and safety of weekly subcutaneous administrations of VK2735 in obese adults and in obese or overweight adults with type 2 diabetes mellitus (T2DM).

Trial Design and Endpoints

VANQUISH-1 focuses on approximately 4500 obese adults with body mass index (BMI) ≥30 kg/m² or overweight adults (BMI ≥27) with at least one weight-related comorbidity. VANQUISH-2 enrolls about 1100 obese or overweight T2DM patients. Both trials assess percent change in body weight from baseline at 78 weeks as the primary endpoint, alongside secondary measures including proportions achieving ≥5%, ≥10%, ≥15%, and ≥20% weight loss, glycemic parameters, cardiovascular risk factors, and patient-reported outcomes. Each study includes open-label extensions for continued safety and efficacy follow-up.

Mechanistic Insights and Potential Advantages

VK2735’s dual receptor agonism harnesses the complementary actions of GLP-1 and GIP pathways. GLP-1 receptor activation promotes satiety and insulin secretion, while GIP receptor stimulation may enhance insulin sensitivity and modulate adipose tissue metabolism, potentially offering greater efficacy with an improved side effect profile relative to GLP-1 monotherapy.

CEO Brian Lian stated, “The launch of the VANQUISH Phase 3 program represents a significant step forward toward addressing the urgent need for more effective therapies in obesity and type 2 diabetes with a differentiated mechanism and better tolerability.”

Safety and Monitoring

Earlier phase studies reported manageable gastrointestinal side effects typical of incretin therapies, with emerging data suggesting a favorable tolerability profile that may enhance adherence and patient outcomes during long-term treatment.

Industry and Market Context

Obesity and T2DM continue to represent critical public health challenges worldwide, with current treatment options often limited by efficacy, safety, or adherence issues. VK2735 aims to fill these gaps by potentially delivering superior weight management and glycemic control, thus improving long-term morbidity and mortality.

Next Steps and Regulatory Outlook

Viking Therapeutics plans to report interim data and regulatory submissions following the completion of primary endpoints. The company anticipates that positive Phase 3 results will position VK2735 competitively in a rapidly evolving metabolic disease therapy landscape.