Single ascending dose study evaluating safety, tolerability, and pharmacokinetics of VK3019
Potential to further expand Viking's treatment options for weight loss
SAN DIEGO, June 24, 2026 /PRNewswire/ -- 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.
About VK3019
VK3019 is an investigational dual amylin and calcitonin receptor agonist (DACRA) in development as a potential new treatment option for weight loss. It 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.
About Amylin and Calcitonin
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 β-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.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.
For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK3019, VK0214, VK2809, and the company's other incretin and other receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission including Viking's Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.
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SOURCE Viking Therapeutics, Inc.
