Viking Therapeutics has initiated a Phase 1 clinical study of VK3019, an investigational dual amylin and calcitonin receptor agonist being developed as a potential treatment option for weight loss.
The study follows FDA clearance of VK3019’s Investigational New Drug application. It is a randomised, double-blind, placebo-controlled single ascending dose trial in healthy adults with a body mass index of at least 30.
This is relevant because obesity drug development is expanding beyond GLP-1 and GLP-1/GIP receptor agonists. While those therapies have reshaped the metabolic disease market, there remains demand for additional mechanisms that can improve weight-loss induction, support maintenance and address tolerability or adherence issues.
VK3019 targets amylin and calcitonin receptors. Amylin is co-secreted with insulin and helps regulate satiety, gastric emptying and post-meal glucagon release. Calcitonin receptor activation may provide additional metabolic effects, including more acute reductions in food intake and potential benefits for glucose regulation and insulin sensitivity.
The Phase 1 trial will evaluate safety, tolerability and pharmacokinetics after single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments will include changes in body weight after a single administration.
Viking said preclinical data from its internally developed dual amylin and calcitonin receptor agonists showed effects on body weight, food intake and metabolism in healthy rats and diet-induced obese mice. In lean rats, the compounds reduced food intake within 0 to 72 hours after a single dose. At 72 hours, body weight was reduced by up to 8 per cent compared with controls.
The candidate adds another layer to Viking’s metabolic pipeline. The company is already conducting Phase 3 VANQUISH studies of subcutaneous VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity and in adults with obesity and type 2 diabetes.
Viking is also advancing an oral tablet formulation of VK2735 and plans to initiate a Phase 3 trial of oral VK2735 for obesity and overweight later in 2026. The company believes having both oral and injectable versions of the same active ingredient could support differentiated long-term treatment strategies.
VK3019 may be developed as a standalone therapy or potentially in combination with GLP-1 or dual GLP-1/GIP therapies. This is commercially relevant because obesity treatment is moving toward more personalised regimens, where induction, maintenance, route of administration and tolerability may affect long-term adherence.
