Announcement • Jun 25

Viking Therapeutics Initiates Phase 1 Single Ascending Dose Clinical Trial of VK3019 in Healthy Adults

Viking Therapeutics, Inc. initiated a Phase 1 single ascending dose (SAD) clinical trial of VK3019, an investigational dual amylin and calcitonin receptor agonist (DACRA). VK3019 is being developed as a potential treatment option for weight loss. The study initiation follows the filing and clearance of VK3019's investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA). The Phase 1 trial is a randomized, double-blind, placebo-controlled SAD study in healthy adults with BMI =30. The primary objectives of the study include evaluating the safety, tolerability, and pharmacokinetics of single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments include evaluations of changes in body weight after a single-dose administration. Preclinical data from Viking's internally developed DACRAs showed impressive effects on body weight, food intake, and metabolism in healthy rats and diet-induced obese (DIO) mice compared to control-treated animals. Results showed Viking's DACRAs reduced food intake in lean rats within 0 to 72 hours after a single dose. At 72 hours, these compounds reduced body weight by up to 8% compared to controls. VK3019 is currently being evaluated in a single ascending dose study assessing safety, tolerability, and pharmacokinetics of VK3019 for the treatment of metabolic disorders and obesity. Amylin and calcitonin receptors play an important role in food intake and metabolic control. Amylin is a peptide hormone co-secreted with insulin from pancreatic ß-cells that slows gastric emptying and suppresses postprandial glucagon secretion, promoting satiety and regulating blood glucose. After a meal, amylin is secreted from the pancreas and circulates in the blood to activate specific receptors in the brainstem. This results in suppression of glucagon release from the pancreas, reduced food intake, and slowed gastric emptying. The net effect of these actions is to decrease blood glucose and is associated with longer-term reductions in body weight. Calcitonin is a peptide hormone produced by the thyroid gland known for its role in regulating calcium homeostasis. To date, the addition of calcitonin receptor activation by DACRAs has demonstrated additional metabolic benefits not seen with amylin receptor activation alone, such as improved fasting glucose regulation and insulin sensitivity, and can result in a more acute reduction of food intake and greater body weight loss. In addition to the Phase 1 trial of VK3019, Viking is currently conducting the Phase 3 VANQUISH studies of subcutaneous VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, in patients with obesity or who are overweight. The VANQUISH program consists of two trials evaluating VK2735: one in adults with obesity (VANQUISH-1), and another in adults with obesity and type 2 diabetes (VANQUISH-2). Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. In parallel with the development of a subcutaneous formulation, Viking is advancing an oral tablet formulation of VK2735. If successful, oral VK2735 would represent the first oral dual agonist to reach the market. The company believes the availability of both oral and injectable formulations is a key differentiating feature of VK2735, compared with competitive agents, as no other dual or triple agonist is currently available in both formulations. Using the same active ingredient across formulations may also reduce the risk of unexpected side effects compared with switching between therapies that do not share the same active agent. The company plans to initiate a Phase 3 trial to evaluate oral VK2735 for the treatment of obesity and overweight later this year. Based on VK2735's promising efficacy and differentiated pharmacokinetic (PK) profile, the company is evaluating a range of novel dosing regimens for both the induction and the long-term maintenance of weight loss. In October 2025, Viking initiated a Phase 1 study designed to explore the feasibility of various VK2735 maintenance dosing regimens. Providing flexible dosing options for long-term therapy may improve treatment persistence following achievement of individual weight loss goals. The company expects to report the results of the study in Third Quarter 2026.

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