Viking Therapeutics Initiates Phase 1 Ascending Dose Trial Of VK3019, An Investigational Dual Amylin And Calcitonin Receptor Agonist For Weight Loss; Data Expected In 3Q26

Viking Therapeutics, Inc. ("Viking") (NASDAQ:VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced today the initiation of 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.

"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," said Brian Lian, Ph.D., chief executive officer of Viking. "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."

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. 

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 believes this may lead to improved adherence to therapy and increase the probability of realizing the long-term benefits of weight loss, such as reduced cardiovascular risks, improved physical function, and enhanced quality of life.  The company expects to report the results of the study in 3Q26.