Viking Therapeutics Launches Phase 3 Clinical Trials for VK2735 in Obesity Treatment

Viking Therapeutics Advances Obesity Treatment with VK2735

Viking Therapeutics, Inc., a prominent clinical-stage biopharmaceutical company, has announced the onset of its Phase 3 clinical program, named VANQUISH, for VK2735. This clinical program aims to address obesity and improve outcomes for those suffering from metabolic and endocrine disorders. The introduction of VK2735 is seen as a significant advancement in therapeutic options for obesity, a condition affecting millions globally.

VK2735 functions as a dual agonist for the glucagon-like peptide 1 (GLP-1) receptor and the glucose-dependent insulinotropic polypeptide (GIP) receptor, highlighting its innovative approach in treating weight-related health issues. The program will assess VK2735 in both subcutaneous and oral forms, allowing for flexibility in treatment options.

Details of the VANQUISH Phase 3 Program

The VANQUISH program encompasses two crucial studies designed to evaluate VK2735’s safety and efficacy. The first study, VANQUISH-1, seeks to enroll around 4,500 obese adults (with a BMI of 30 or higher or a BMI of 27 or higher with co-morbid conditions). The second, VANQUISH-2, targets approximately 1,100 obese or overweight adults with type 2 diabetes. Both studies will be randomized, double-blind, placebo-controlled, and will administer VK2735 through subcutaneous injection on a weekly basis for a total of 78 weeks.

The primary endpoint for these studies is the percentage change in body weight from the baseline after 78 weeks, compared to placebo. Secondary endpoints include assessing the percentage of participants achieving significant weight loss, with varying thresholds such as ≥5%, ≥10%, ≥15%, and ≥20% weight reduction. Notably, there will be an open-label extension period post-study, allowing participants to continue receiving VK2735, thereby closely monitoring long-term effects and benefits.

Positive Insights from Previous Trials

Viking has already observed promising results from its Phase 2 VENTURE study involving VK2735. This earlier clinical trial reported significant reductions in body weight among participants treated with VK2735 compared to those receiving placebo. Notably, patients exhibited an impressive mean weight loss of up to 14.7%, demonstrating VK2735's effectiveness over just 13 weekly doses. Longitudinal data also indicated that the participants largely maintained their weight loss several weeks after completion of the treatment.

Moreover, VK2735 was well-tolerated among participants, with adverse effects primarily mild to moderate in severity. Gastrointestinal side effects were recorded, but these typically diminished over the course of the trial, reaffirming the drug's favorable safety profile.

Understanding GLP-1 and GIP Agonists

The mechanisms by which VK2735 operates are vital to its therapeutic benefits. GLP-1 receptor activation has been linked to various positive outcomes in managing diabetes and obesity, including appetite suppression, reduced body weight, and improved insulin sensitivity. Recent research has expanded into GIP co-activation, enhancing potential treatment efficacy for patients.

Noteworthy examples of GLP-1 receptor agonists already in therapeutic use include Semaglutide, marketed under various names such as Ozempic®, Rybelsus®, and Wegovy®. Furthermore, Tirzepatide, another dual agonist with approval from the FDA, illustrates the growing interest and investment in this treatment avenue.

The Road Ahead for Viking Therapeutics

As Viking Therapeutics moves forward with the VANQUISH program, the company is also preparing to launch additional studies to explore a monthly maintenance dosing regimen. Moreover, results from the Phase 2 trial on the oral formulation of VK2735 are anticipated later this year, adding to the growing body of research surrounding this innovative therapy.

Viking's commitment to developing pioneering treatments for metabolic disorders is further evidenced through other projects, including VK2809, aimed at addressing lipid and metabolic disorders and VK0214, focused on rare diseases such as X-linked adrenoleukodystrophy.

In summary, the initiation of the VANQUISH Phase 3 program marks a pivotal chapter in Viking Therapeutics' journey, bringing hope to those impacted by obesity and related conditions. As these studies unfold, the medical community anticipates significant advancements in treatment options that could transform patients' lives significantly.