Viking Therapeutics Inc. (VKTX), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced Tuesday positive results from Phase 1 clinical trial of Dual GLP-1/GIP Receptor Agonist VK2735.
Based on these results from Phase 1 single ascending dose or SAD and multiple ascending dose or MAD clinical trial, the company plans to initiate a Phase 2 study of VK2735 in patients with obesity in mid-2023.
VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders.
The company said up to 6.0% placebo-adjusted mean weight loss was observed after 28 days. VK2735 was shown to be safe and well-tolerated in 28-day study.
The company noted that in the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic (PK) profile.
In the 28-day MAD portion of the study, VK2735 demonstrated encouraging tolerability and positive signs of clinical activity.
Viking said it plans to evaluate further dose escalation in the upcoming Phase 2 trial.
Brian Lian, chief executive officer of Viking, said, “The initial data suggest excellent clinical characteristics, with good tolerability and up to approximately 18 pounds of mean weight loss from baseline. Though subjects in this study were only exposed to higher doses for a limited time, no signs of plateau were observed. We look forward to exploring higher doses over a longer treatment window in the Phase 2 trial.”
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