Viking Therapeutics Announces Initiation of VK2735 Oral Maintenance Dosing Clinical Trial in Patients with Obesity

Viking Therapeutics Announces Initiation of VK2735 Oral Maintenance Dosing Clinical Trial in Patients with Obesity

Study to Explore Oral Maintenance Dosing Regimens Following Initial Weight Loss with Subcutaneous VK2735

Monthly and Every-Other-Week Subcutaneous Regimens to also be Evaluated

, / 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 initiation of an exploratory oral 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 trial announced today is the second in a two-part maintenance study initiated in 2025. Positive top-line results were recently announced from Part 1 of this study, which evaluated various subcutaneous dosing regimens for their potential to maintain the initial weight loss achieved with weekly subcutaneous dosing. Part 2 of the study is designed to explore the potential of various VK2735 oral tablet dosing regimens as well as additional subcutaneous dosing regimens to maintain the initial weight loss achieved from weekly subcutaneous dosing.

The maintenance dosing study is a randomized, double-blind, placebo-controlled trial in approximately 195 adults with obesity (BMI ≥30 kg/m 2 ) who are otherwise healthy. As in Part 1 of the study, all participants will receive initial weekly subcutaneous doses of VK2735 or placebo for 21 weeks. Following Week 21, participants will transition to a range of VK2735 maintenance dosing options including daily oral doses, weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. The study objectives are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints will assess changes in body weight from baseline and from Week 21 to the end of the study at Week 33.

"Our recent top-line results from Part 1 of this study demonstrated the potency and differentiated profile of VK2735 in the setting of both weight loss induction and potentially longer-term maintenance. We are eager to continue this study with the initiation of Part 2, which will explore multiple regimens, both oral and subcutaneous, with the potential to provide greater optionality and flexibility to best align with a patient's individual weight loss journey," said Brian Lian, Ph.D., chief executive officer of Viking. "Adherence to therapy is critical to achieving the long-term benefits of weight loss, including reduction of cardiovascular risk, improved physical function, and enhanced quality of life. We believe flexibility and optionality are key to increasing adherence to treatment and improving long-term weight management - from induction to maintenance. We were pleased to report positive results from our recent subcutaneous maintenance study and are excited by the potential to validate additional maintenance regimens as well. In doing so, we expect to offer patients and their clinicians a broad range of highly effective and convenient tools to achieve personalized weight loss goals. We look forward to reporting the results from Part 2 of this study in 2027."

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 is fully enrolled with approximately 4,500 adults who do not have type 2 diabetes and who have obesity (BMI ≥30 kg/m 2 ) or are overweight (BMI ≥27 kg/m 2 ) with at least one weight-related co-morbid condition. The VANQUISH-2 study is also fully enrolled with approximately 1,000 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 advancing a next-generation portfolio of therapies for obesity and metabolic disease. Guided by deep expertise in metabolic biology and rigorous science, Viking is developing innovative treatments to help people achieve meaningful, lasting health improvements by treating obesity first. The company's lead program, VK2735, is a dual glucagon-like peptide 1 ( GLP-1 ) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist in development in both subcutaneous and oral formulations for obesity. VK2735 is currently being evaluated in Phase 3 clinical studies for obesity, along with maintenance dosing strategies designed to support long-term weight management. Viking is also advancing additional obesity programs, including VK3019, an amylin receptor agonist, VK2809, an orally available thyroid hormone receptor beta agonist for metabolic and liver disease, and VK0214 for the rare genetic disorder X-linked adrenoleukodystrophy (X-ALD).

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.

SOURCE Viking Therapeutics, Inc.

For further information: Contacts: Viking Therapeutics, Inc., Greg Zante, Chief Financial Officer, 858-704-4672, [email protected]; Vida Strategic Partners, Stephanie Diaz (Investors), 415-675-7401, [email protected]; Jennifer Arcure (Media), 917-603-0681, [email protected]