Viking Therapeutics has reported positive data from its Phase I multiple ascending dose (MAD) clinical trial of VK2735, an oral tablet under investigation for the treatment of metabolic disorders, such as obesity.
VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
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The Phase I MAD study of oral VK2735 is a continuation of the company’s initial Phase 1 single ascending dose (SAD)/MAD trial, which involved subcutaneous administration of VK2735.
The randomised, double-blind, placebo-controlled oral section of the trial enrolled healthy adult subjects with a body mass index of at least 30kg/m².
Assessing the safety and tolerability of the oral therapy when administered once daily for 28 days was the trial’s primary goal.
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Variations in body weight and other metrics were the trial’s exploratory pharmacodynamic measures.
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By GlobalDataAccording to the results from the 28-day MAD study, oral VK2735 demonstrated signs of clinical activity.
Participants who received VK2735 experienced dose-dependent reductions in mean body weight from baseline, with decreases of up to 5.3%.
Compared to the placebo, the reductions in mean body weight was up to 3.3%.
The company observed a promising trajectory of weight loss, suggesting that extending the treatment duration beyond 28 days could lead to further reductions in body weight.
VK2735 was found to be safe and well-tolerated, with all treatment-emergent adverse events (TEAEs) observed to be mild or moderate in nature.
Based on these results, Viking is preparing to launch a Phase II trial with the oral VK2735 for obesity in the second half of this year.
Viking Therapeutics CEO Brian Lian said: “These Phase I results highlight VK2735’s promising early weight loss and tolerability profile when dosed as an oral tablet.
“We believe these data indicate that longer treatment duration, at potentially higher doses, may result in additional weight loss.
“We are particularly pleased with the initial safety and tolerability data, which suggest a differentiated profile with minimal gastrointestinal-related side effects.”
In February, the company reported topline results from a Phase II trial of VK2735 over 13 weeks in adults who are either obese or overweight.
