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Results of Phase II Clinical Trial Show Promise for Potential Obesity Treatment

Image Credit: © putilov_denis – stock.adobe.com

Viking Therapeutics has announced positive top-line results from its Phase II clinical trial of VK2735, a potential therapy for obesity, according to a company press release.1 VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders, including obesity.

According to the Centers for Disease Control and Prevention, United States obesity prevalence in adults was 41.9 percent in 2017 through March 2020. From 1999-2000 through 2017-March 2020, obesity prevalence increased from 30.5% to 41.9%. Obesity-related conditions include heart disease, stroke, and certain types of cancer.2

The Phase II VENTURE trial was a randomized, double-blind, placebo-controlled study intended to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly. The 13-week trial enrolled 176 adults who are obese or adults who are overweight with at least one weight-related comorbid condition.

Patients receiving weekly doses of VK2735 showed significant reductions in body weight, ranging up to 14.7 percent from the baseline, successfully achieving its primary endpoint and all secondary endpoints compared to the placebo.

“We are excited to report the top-line results from this important Phase II study. VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects,” said Brian Lian, PhD, chief executive officer of Viking in the press release. “Notably, robust weight loss compared with placebo was observed early across all doses evaluated in the VENTURE study, and continued throughout the treatment period in all treatment groups. No evidence of a plateau was observed at week 13 for any VK2735 dose, suggesting further weight loss might be achieved from extended dosing periods. We look forward to progressing this important therapy into further clinical development later this year. Separately, we remain on track to report data from a Phase I study of an oral formulation of VK2735 later this quarter.”

Additionally, the study showed VK2735 treatment to be safe and well tolerated with the majority of treatment emergent adverse events being categorized as mild or moderate. Following the promising Phase II study, Viking intends to meet with FDA regarding next steps to further advance research of the potential therapy.

References

  1. Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity. News release. February 27, 2024. Accessed February 28, 2024. https://www.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-trial-of-dual-glp-1gip-receptor-agonist-vk2735-in-patients-with-obesity-302072459.html
  2. Adult Obesity Facts. Centers for Disease Control and Prevention. May 17, 2022. Accessed February 28, 2024. https://www.cdc.gov/obesity/data/adult.html