Pfizer (NYSE:PFE) announced positive topline results from the Phase 2b VESPER-3 study evaluating monthly maintenance dosing of its fully-biased, ultra-long-acting injectable GLP-1 receptor agonist PF’3944 (nexiguran ziclumeran) in adults with obesity or overweight without type 2 diabetes.
The study met both primary objectives: demonstrating continued weight loss after switching from weekly to monthly subcutaneous injections (four-fold reduction in dosing frequency) and maintaining efficacy while preserving a well-tolerated safety profile.
At week 28, placebo-adjusted weight loss reached up to 12.3% (efficacy estimand), with the primary endpoint of weight reduction from randomization to week 28 showing statistical superiority to placebo across all four dose regimens tested (P < 0.001).
No plateau in weight loss was observed at week 28, suggesting potential for further reductions through the ongoing 64-week study.
The trial included up to two titration steps with weekly dosing through week 12, followed by monthly dosing to week 28.
The low (3.2 mg) and medium (4.8 mg) monthly maintenance regimens planned for Phase 3 achieved 10% and 12.3% placebo-adjusted weight loss, respectively.