Viking Therapeutics Presents Positive Data from VK2735 for Reducing Body Weight Effectively and Safely

Image Credit: Adobe Stock Images/Maya Kruchancova

Data from the Phase II VENTURE trial and a Phase 1 multiple ascending dose (MAD) trial found that Viking Therapeutics’ VK2735, a novel dual GLP-1 and GIP receptor agonist, demonstrated promise in reducing body weight effectively and safely in patients with obesity. According to the company, preliminary data indicated potential glycemic benefits, with a reduction in prediabetic patients progressing to normoglycemia. Results were presented at the 2024 ObesityWeek conference.¹

In the Phase I MAD trial, patients received doses of 60 mg, 80 mg, and 100 mg daily for 28 days to compare with placebo. Results demonstrated a mean weight loss of up to 8.2% from baseline by day 28, with sustained weight loss ranging up to 8.3% observed at follow-up. Additionally, patients demonstrated reductions in mean body weight relative to placebo, ranging up to 6.8%. Further, an assessment found that patients achieving at least 5% weight loss after 28 days demonstrated that up to 100% of VK2735-treated subjects achieved ≥5% weight loss, compared with 0% for placebo.

Following 28 days of once-daily dosing, oral VK2735 continued to demonstrate encouraging safety and tolerability. A majority of adverse events (AEs) were reported to be mild or moderate. Further, mild or moderate gastrointestinal AEs were reported, with 84% being reported as mild. Additionally, mild nausea was reported in 32% of patients in the VK2735 group and 11% in the placebo group.¹

VENTURE was a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously (SC), once weekly. Consisting of 176 patients, the primary endpoint of the study was the percentage change in body weight from baseline to week 13 in patients treated with VK2735 compared to placebo. Secondary endpoints aimed to evaluate a range of additional safety and efficacy measures.²

Results of the trial found that SC VK2735 demonstrated up to 14.7% weight loss from baseline, with 88% of patients achieving ≥10% weight loss compared to just 4% in the placebo group.

Similar to the MAD trial, the VENTURE study demonstrated favorable safety and tolerability, with most AEs being mild or moderate. Ninety-five percent of treatment-emergent AEs were gastrointestinal. Around 68% of patients treated with VK2735 experienced nausea, with 18% also reporting vomiting.¹

"We are happy to report the updated results from both the VENTURE Phase II study and the oral Phase I study," said Brian Lian, PhD, CEO, Viking, in a press release. "We believe the VENTURE data demonstrate VK2735's promising efficacy and tolerability profile through 13 weeks of weekly dosing and support our belief that less frequent dosing regimens may provide effective maintenance of weight control. The updated oral Phase I study results continue to demonstrate an encouraging tolerability profile and promising signs of clinical activity at doses of up to 100 mg daily. We believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss."

Viking anticipates advancing clinical discussions with the FDA on the injectable formulation and initiating a Phase II study for the oral tablet by year-end, with further study design details expected in the near future.¹

References

1. Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024. PR Newswire. November 4, 2024. Accessed November 4, 2024. https://www.prnewswire.com/news-releases/viking-therapeutics-reports-new-data-from-vk2735-obesity-program-at-obesityweek-2024-302294915.html

2. Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity. Viking. February 27, 2024. Accessed November 4, 2024. https://ir.vikingtherapeutics.com/2024-02-27-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Patients-with-Obesity