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

Core Insights - Viking Therapeutics has completed patient enrollment in a Phase 1 maintenance dosing study for VK2735, a dual agonist targeting GLP-1 and GIP receptors, aimed at treating metabolic disorders like obesity [1][2]. Group 1: Study Details - The maintenance dosing study is a randomized, double-blind, placebo-controlled trial involving approximately 180 healthy adults with a BMI of 30 kg/m or higher [2]. - Participants initially receive weekly subcutaneous doses of VK2735 or placebo for 19 weeks, followed by various maintenance dosing regimens including weekly, bi-weekly, or monthly subcutaneous doses, as well as daily and weekly oral dosing options [3]. - The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735, with exploratory endpoints focusing on changes in body weight from baseline and from Week 19 to Week 31 [3]. Group 2: Company Strategy and Product Differentiation - The development of effective maintenance dosing regimens is crucial for achieving long-term health benefits from weight loss, potentially differentiating VK2735 from existing obesity treatments [4]. - The same dual-acting GLP-1/GIP agonist is utilized in both subcutaneous and oral formulations, offering treatment flexibility and potentially improved adherence to therapy [4]. Group 3: Ongoing Clinical Trials - Viking is also conducting two Phase 3 studies (VANQUISH-1 and VANQUISH-2) to assess the efficacy and safety of subcutaneous VK2735 over 78 weeks, with VANQUISH-1 enrolling approximately 4,650 adults with obesity or overweight conditions, and VANQUISH-2 enrolling around 1,100 adults with type 2 diabetes [5]. - Patients in these trials are randomized into four treatment arms, receiving either VK2735 at doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo [5]. Group 4: Background on GLP-1 and GIP Agonists - GLP-1 receptor activation has been shown to decrease glucose levels, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes and obesity [6]. - Tirzepatide, a dual GLP-1/GIP receptor agonist, has been approved by the FDA, indicating a growing interest in this class of therapeutics [6]. Group 5: Company Overview - Viking Therapeutics is focused on developing novel therapies for metabolic and endocrine disorders, with VK2735 being a key product in their pipeline [8]. - The company is also advancing VK2809, a selective thyroid hormone receptor beta agonist, and VK0214 for rare diseases, showcasing a diverse portfolio aimed at improving patient outcomes [8].