Study is Evaluating Monthly Subcutaneous, Weekly Oral, and Daily Oral Regimens

Designed to Explore Maintenance Dosing Regimens Following Initial Weight Loss with VK2735

SAN DIEGO, Jan. 8, 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, today announced the completion of patient enrollment in its exploratory maintenance dosing study of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

The maintenance dosing study is a Phase 1, randomized, double-blind, placebo-controlled trial designed to evaluate various dosing regimens, following initial weight loss achieved with weekly VK2735 treatment. The trial enrolled approximately 180 adults with BMI ≥30 kg/m² but who are otherwise healthy.

All enrolled participants receive initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks. Following Week 19, participants are transitioned to a range of VK2735 maintenance dosing regimens including weekly, every other week, or monthly subcutaneous dosing, as well as daily oral dosing, weekly oral dosing, or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints are assessing change in body weight from baseline, as well as change in body weight from Week 19 to the end of the study at Week 31.

"The successful development of maintenance dosing regimens is critical to realizing the long-term health benefits from weight loss and may provide an opportunity to further differentiate VK2735 from currently available obesity treatments," said Brian Lian Ph.D., chief executive officer of Viking. "Importantly, the same dual-acting GLP-1/GIP agonist molecule is used in both our subcutaneous and oral formulations, which may uniquely enable treatment flexibility with VK2735. Remaining on the same active compound offers the potential for long-term dosing with either tablets or injections with potentially reduced side effects compared with options that require switching between different therapeutic agents. This may improve adherence to treatment, a key factor in achieving the long-term benefits of weight loss such as improved cardiovascular health, enhanced physical function, and increased quality of life. We look forward to reporting the results of this important study later this year."

In addition to the maintenance dosing study, Viking is currently conducting two Phase 3 studies evaluating subcutaneous VK2735 (VANQUISH-1 and VANQUISH-2). These trials are randomized, double-blind, placebo-controlled, multicenter trials designed to assess the efficacy and safety of subcutaneous VK2735 dosed weekly for 78 weeks. The VANQUISH-1 study has completed enrollment of approximately 4,650 adults with obesity (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related co-morbid condition. The VANQUISH-2 study is enrolling approximately 1,100 adults with type 2 diabetes who have obesity or are overweight. Patients in both trials are being randomized to one of four weekly treatment arms: VK2735 7.5 mg; VK2735 12.5 mg; VK2735 17.5 mg; and placebo.

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, VK0214, VK2809, and the company's other incretin 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, 2024, 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.

Viking Therapeutics Announces Completion of Enrollment in Maintenance Dosing Clinical Trial of VK2735 in Obesity