Viking Therapeutics’ GLP-1/GIP Receptor Agonist Shows Positive Results in Obesity Clinical Trial

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Viking Therapeutics revealed that it has achieved positive results from the Phase II VENTURE trial for VK2735, a dual GLP-1/GIP receptor agonist aimed at treating obesity. According to the company, the trial successfully met all of its endpoints, showing major improvements in patients treated with VK2735 as opposed to those treated with a placebo. Results also show that the treatment was safe, with most reported adverse reactions being mild or moderate, particularly regarding gastrointestinal issues. During the 13-week study, investigators found that approximately 88% of patients experienced at least 10% weight loss.¹

"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, CEO, Viking, in a 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 1 study of an oral formulation of VK2735 later this quarter."

Back in October, Viking presented data from its Phase I trial at ObesityWeek 2023, showing significant reductions in liver fat content and plasma lipid levels in patients after weekly treatments of VK2735 for 28 days. Remarkably, individuals with non-alcoholic fatty liver disease (NAFLD) experienced an approximately 58.5% reduction in liver fat compared to placebo. Further, Viking reported that the treatment produced dose-dependent decreases in levels of apolipoprotein B, low-density lipoprotein cholesterol, and total cholesterol, without meaningful changes in high-density lipoprotein cholesterol levels.²

"These new data demonstrate VK2735's rapid and promising impact on liver fat and plasma lipids on top of the previously reported reductions in body weight," said Lian, in another release. "We believe these results suggest broader potential benefits on a patient's overall metabolic health, in tandem with weight loss, and may indicate utility in patients with obesity, NAFLD, and NASH. We look forward to building upon the Phase 1 data with results from our ongoing Phase 2 VENTURE study, which is evaluating VK2735's safety and efficacy in patients with obesity over a 13-week treatment period."

In September, Viking initiated its Phase II VENTURE trial, working as a randomized, double-blind, placebo-controlled study that evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of four different doses of VK2735, enrolling a total of 125 test subjects.³

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. PR Newswire. 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. Viking Therapeutics Presents New Data from Phase 1 Clinical Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Oral Presentation at ObesityWeek 2023. Viking Therapeutics. October 17, 2023. Accessed February 28, 2024. http://ir.vikingtherapeutics.com/2023-10-17-Viking-Therapeutics-Presents-New-Data-from-Phase-1-Clinical-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Oral-Presentation-at-ObesityWeek-2023

3. Viking Therapeutics Announces Initiation of Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity. PR Newswire. September 6, 2023. Accessed February 28, 2024. https://www.prnewswire.com/news-releases/viking-therapeutics-announces-initiation-of-phase-2-venture-trial-of-dual-glp-1gip-receptor-agonist-vk2735-in-patients-with-obesity-301918600.html