Viking Therapeutics has begun the VANQUISH Phase III clinical programme of the dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, VK2735, intended for the potential treatment of obesity.
This programme comprises two double-blind, randomised, multicentre, placebo-controlled trials to assess the safety and efficacy of the therapy as a subcutaneous (SC) injection administered once weekly for a 78-week period.
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The VANQUISH-1 trial aims to enrol approximately 4,500 obese or overweight subjects with related co-morbid conditions.
VANQUISH-2 will target nearly 1,100 obese or overweight adults with type 2 diabetes.
The primary endpoint of these trials is the percentage change in body weight from baseline after 78 weeks of treatment with VK2735, against a placebo.
Secondary and exploratory endpoints will include various additional efficacy and safety metrics, such as the percentage of subjects achieving a significant reduction in body weight.
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By GlobalDataEach trial will also feature an open-label extension, offering subjects the option to continue treatment after the primary dosing period.
Viking Therapeutics CEO Brian Lian said: “Along with the successful initiation of the Phase III programme, we continue to make progress on VK2735’s broader development. This includes our plans to initiate an additional clinical study to evaluate a monthly maintenance regimen, which is expected to begin later this year.
“We also continue to build on the encouraging early data reported for the oral tablet formulation of VK2735 and expect to report the results of the Phase II VENTURE-Oral Dosing study in the second half of this year.”
This development follows the positive top-line outcomes from the Phase II VENTURE trial of SC VK2735 for treating obesity.
Last year, the company reported positive outcomes from its Phase Ib trial of thyroid hormone receptor beta agonist, VK0214, in individuals with X-linked adrenoleukodystrophy.
