Viking Therapeutics, Inc. VKTX on Wednesday initiated the VANQUISH Phase 3 clinical program for VK2735, the company’s dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
VK2375 is being developed in oral and subcutaneous formulations for metabolic disorders such as obesity.
The VANQUISH Phase 3 program includes two studies evaluating VK2735: one in adults with obesity and one in obese or overweight adults with type 2 diabetes.
Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.
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VANQUISH-1 study: The study will target enrollment of approximately 4,500 obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) adults with at least one weight-related co-morbid condition.
VANQUISH-2 study: The study will target enrollment of approximately 1,100 adults with type 2 diabetes who are obese or overweight.
Participants in both trials will be randomized to one of four weekly treatment arms: VK2735 7.5 mg, VK2735 12.5 mg, VK2735 17.5 mg, and placebo, slightly higher than the currently approved Eli Lilly And Co.’s LLY Zepbound doses of 5 mg, 10 mg and 15 mg.
The trials’ primary endpoint is the percent change in body weight from baseline for participants receiving VK2735 compared to placebo after 78 weeks of treatment.
Secondary and exploratory endpoints will evaluate additional safety and efficacy measures, including the percentage of patients who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction.
Each study will include an open-label extension, allowing participants to continue receiving treatment after the primary dosing period is completed.
In 2024, Viking announced topline results from the Phase 2 VENTURE study of subcutaneous VK2735 in obesity.
The VENTURE trial successfully achieved its primary and all secondary endpoints, with patients receiving VK2735 demonstrating clinically meaningful reductions in body weight compared with placebo.
Patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%, and statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%.
Differences compared to placebo were statistically significant for all doses starting at week one and were maintained throughout the study.
In addition, results from follow-up visits four and seven weeks after the last dose of VK2735 was administered showed that cohorts receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up visit after administering the final dose.
VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with most observed adverse events (AEs) being reported as mild or moderate.
Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo. Of gastrointestinal (GI) related AEs, 95% were reported as mild or moderate.
Why it Matters: William Blair notes some obesity experts said that insurance companies often won’t cover certain “non-standard” Zepbound doses like 2.5 mg, 7.5 mg and 12.5 mg, even though these may be the best long-term doses for some patients.
While large academic hospitals with specialized reimbursement teams can usually work around this issue, smaller or community clinics may benefit from approving these in-between doses, as it could make treatment more accessible for more patients.
Analyst Andy Hsieh expects that 17.5 mg VK2735 could contribute to additional weight loss over 15 mg Zepbound and surmises there could be a potential ceiling effect when it comes to increasingly higher doses of Zepbound or VK2735.
“We continue to believe that Viking’s obesity franchise offers a unique set of attractive qualities that will be viewed favorably in the lens of big pharma from an M&A perspective…,” William Blair analyst wrote on Wednesday.
VKTX Price Action: VKTX stock is down 1% at $26.68 at publication on Wednesday.
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