Development

Viking reports positive monthly and every-other-week VK2735 maintenance data

Viking reports positive monthly and every-other-week VK2735 maintenance data

Subcutaneous VK2735, Viking Therapeutics’ (Nasdaq: VKTX) dual GLP-1/GIP receptor agonist, maintained most of the weight loss achieved during weekly induction when participants switched to every-other-week or monthly dosing for 12 weeks, providing early evidence that less-frequent maintenance regimens may be feasible

Viking reported topline results from the VK2735-102 maintenance study, a Phase I, randomized, double-blind, placebo-controlled trial in approximately 180 adults with obesity (BMI ≥30 kg/m²). The study enrolled participants for a 21-week weekly subcutaneous induction phase, then transitioned them to either every-other-week or monthly dosing for 12 weeks, with an exploratory cohort continuing weekly dosing through Week 33. Notably, the body weight and safety endpoints in VK2735-102 were exploratory, with safety, tolerability, and pharmacokinetics the primary objectives.

VK2735 co-activates the GLP-1 and GIP receptors, a mechanism that suppresses appetite, slows gastric emptying, and improves insulin sensitivity. Because Viking is developing both oral and injectable formulations of the same molecule, the company sees potential for different formulations to be used across induction and maintenance strategies.

During the 21-week induction phase, VK2735 cohorts lost approximately 16% to 19% of body weight versus approximately 0% for placebo (p<0.0001 vs. baseline and placebo, all cohorts). The exploratory weekly control arm continued to lose weight without plateau, reaching approximately 22% placebo-adjusted reduction at Week 33. These induction figures are higher than those reported in the Phase II VENTURE trial, which showed up to 14.7% weight loss from baseline after 13 weeks, consistent with the longer treatment duration and accelerated titration used in VK2735-102.

During the 12-week maintenance phase, participants switched to every-other-week dosing retained an average 90% of the weight loss achieved during weekly induction, while those switched to monthly dosing retained 85%, compared with 61% among participants transitioned to placebo. The best-performing regimens maintained 97% of prior weight loss with every-other-week dosing and 90% with monthly dosing. Both reduced-frequency groups separated from placebo within four weeks.

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GI adverse event rates during the 12-week maintenance period were not meaningfully different from placebo across nausea, vomiting, diarrhea, and constipation. Discontinuations due to adverse events were 3% in the combined every-other-week group and 2% in the combined monthly group. Overall treatment-emergent adverse event rates were numerically lower in the every-other-week cohorts (38%) than in placebo (52%).

Wegovy (semaglutide) and Zepbound (tirzepatide) are approved as once-weekly injections, with no approved every-other-week or monthly maintenance regimens. If VK2735 can reproduce the Phase I maintenance findings in larger studies, less-frequent dosing could provide a point of differentiation in the injectable obesity market. Its overall competitive profile will still depend on efficacy and safety data from the ongoing Phase III VANQUISH-1 and VANQUISH-2 trials.


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