Key Takeaways:
Viking Therapeutics Inc. initiated a Phase 1 single ascending dose trial of VK3019, an investigational dual amylin and calcitonin receptor agonist for weight loss, the company said Wednesday.
"The initiation of VK3019's Phase 1 study marks an important expansion of our portfolio of novel therapies designed to optimize the weight loss journey for patients and their physicians," Brian Lian, chief executive officer of Viking, said in a statement.
The randomized, double-blind, placebo-controlled study will evaluate safety, tolerability and pharmacokinetics of single subcutaneous doses in healthy adults with a body mass index of 30 or higher. Exploratory assessments include changes in body weight after a single dose. Preclinical data showed Viking's DACRAs reduced body weight by as much as 8% at 72 hours after a single dose in diet-induced obese mice, compared with controls.
VK3019 targets amylin and calcitonin receptors, mechanisms that regulate food intake and metabolic control. Amylin, a peptide hormone co-secreted with insulin, slows gastric emptying and suppresses postprandial glucagon secretion, while calcitonin receptor activation has demonstrated additional metabolic benefits including improved fasting glucose regulation and insulin sensitivity. The approach may be used alone or in combination with GLP-1 therapies, Lian said, potentially broadening options for patients who cannot tolerate GLP-1-based treatments.
The trial initiation follows the clearance of VK3019's investigational new drug application with the US Food and Drug Administration. Viking is simultaneously advancing VK2735, its dual GLP-1 and GIP receptor agonist, through Phase 3 VANQUISH studies in obesity, with both subcutaneous and oral formulations in development. The company expects to report results from a VK2735 maintenance dosing study in the third quarter of 2026.
Viking reported a first-quarter net loss of $158.3 million, or $1.37 a share, wider than the consensus estimate of a $0.91 per-share loss, driven by a sharp increase in research and development spending. The company ended the quarter with about $603 million in cash, cash equivalents and short-term investments.
The Phase 1 data will determine whether VK3019 can replicate its preclinical weight-loss signals in humans. Investors will watch for topline safety and pharmacokinetic results, which Viking has not yet scheduled for disclosure.
This article is for informational purposes only and does not constitute investment advice.
