Viking Therapeutics has commenced a Phase I clinical trial of VK3019, a dual amylin and calcitonin receptor agonist, which is under development as a potential weight loss treatment option.
The trial follows the US Food and Drug Administration’s acceptance of the investigational new drug application.
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It is a randomised, double-blind, placebo-controlled, single ascending dose trial carried out in healthy adults with a body mass index of 30 or greater.
Primary objectives involve assessing the tolerability, pharmacokinetics and safety of VK3019 delivered as a single subcutaneous dose. Exploratory assessments will track pharmacodynamic changes including body weight after the administration of a single dose.
Viking Therapeutics CEO Brian Lian said: “The initiation of VK3019’s Phase I study marks an important expansion of our portfolio of novel therapies designed to optimise the weight loss journey for patients and their physicians.
“Therapies that target amylin and calcitonin receptors may potentially be used alone or in combination with GLP-1 or dual GLP-1/GIP agonists to improve the induction of weight loss as well as for longer-term weight management.
“Given the complexity of managing obesity and related metabolic conditions, broadening the potential treatment options is crucial to meeting the diverse needs of individuals seeking safe and sustainable weight loss.”
Alongside the VK3019 trial, Viking is conducting the Phase III VANQUISH studies with VK2735, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist, in obese and overweight adults, including those with type 2 diabetes, using both subcutaneous and oral formulations.
In March 2026, Viking Therapeutics completed patient enrolment in its Phase III VANQUISH-2 trial of VK2735, which is being developed in oral and subcutaneous formulations to potentially treat metabolic disorders such as obesity.
