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Viking Therapeutics Completes Enrollment for VK2735 Clinical Trial

Viking Therapeutics, Inc. (NASDAQ: VKTX), a biopharmaceutical company in the clinical stage, has reached a significant milestone by completing patient enrollment in its maintenance dosing clinical trial for VK2735, a dual agonist targeting the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This innovative therapy aims to address a pressing issue: obesity.

The clinical trial, which is currently in Phase 1, adopts a randomized, double-blind, placebo-controlled design. Its objective is to evaluate various maintenance dosing regimens of VK2735 following initial weight loss achieved through weekly treatments. Approximately 180 adult participants, all with a body mass index (BMI) of 30 kg/m² or greater, have been enrolled in this trial, ensuring a diverse representation to test the efficacy and safety of the drug.

Participants will undergo initial weekly subcutaneous dosing for 19 weeks, after which they will transition to the maintenance phase, which includes several options: weekly, bi-weekly, and monthly subcutaneous doses, as well as daily and weekly oral doses. The trial will carefully monitor the safety and tolerability of VK2735 while also assessing its pharmacokinetic profile across these various regimens. Alongside this, exploratory endpoints aim to measure changes in body weight from baseline and at the end of the study period.

According to Brian Lian, Ph.D., the CEO of Viking, the successful establishment of maintenance dosing regimens is vital for reaping the long-term benefits of weight loss, presenting an opportunity to distinguish VK2735 from existing obesity treatments. He emphasizes that utilizing the same drug formulation for subcutaneous and oral delivery modes could enhance treatment flexibility, which may minimize side effects and improve patient adherence. This alignment with long-term treatment goals can significantly impact cardiovascular health and quality of life for patients.

Beyond this trial, Viking Therapeutics is also advancing two Phase 3 studies (VANQUISH-1 and VANQUISH-2) designed to further investigate the efficacy and safety of subcutaneous VK2735 administered weekly over 78 weeks. VANQUISH-1 has already recruited around 4,650 participants suffering from obesity and associated comorbidities, while the VANQUISH-2 trial focuses on over 1,100 individuals diagnosed with type 2 diabetes and obesity or overweight issues. Participants in both studies are assigned to various treatment arms, including doses of VK2735 at 7.5 mg, 12.5 mg, and 17.5 mg, compared against a placebo.

Understanding the Mechanism

The therapeutic promise of VK2735 lies in its action on the GLP-1 receptor, which has been recognized for its ability to reduce glucose levels, curb appetite, decrease body weight, and enhance insulin sensitivity among patients with diabetes and obesity. This mechanism echoes the well-known efficacy of semaglutide, a GLP-1 receptor agonist currently marketed as Ozempic®, Rybelsus®, and Wegovy®.
Research has advanced to not only focus on GLP-1 alone but also consider the co-activation of GIP receptors to boost the therapeutic outcomes associated with GLP-1 receptor stimulation. Tirzepatide stands as an example of a dual GLP-1/GIP receptor agonist already approved by the FDA and marketed under names like Mounjaro® and Zepbound®.

About Viking Therapeutics

Viking Therapeutics is dedicated to developing innovative first-in-class and best-in-class therapies aimed at improving metabolic and endocrine disorders. Its competitive edge lies in leveraging expertise in metabolic pathways to create impactful treatments. Current clinical endeavors include not only VK2735 but also VK2809, which has demonstrated promising results in treating non-alcoholic steatohepatitis (NASH) and related conditions. The company's portfolio also explores treatments in rare diseases, such as VK0214, aimed at X-linked adrenoleukodystrophy (X-ALD).

For continuous updates and detailed information on its groundbreaking programs, Viking Therapeutics encourages interested parties to visit their official website.