The company is developing VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for metabolic ailments such as obesity.
The placebo-controlled, double-blind, randomised trial is designed to assess the tolerability, pharmacokinetics, safety and weight loss efficacy of a subcutaneous, once-a-week dose of VK2735 versus placebo.
It has enrolled nearly 176 adults with obesity or who are overweight with a minimum of one weight-linked comorbid condition.
The percentage change in body weight at week 13 from baseline following treatment with VK2735 is the trial’s primary endpoint.
Various safety and efficacy measures will be analysed as secondary and exploratory endpoints.
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The trial was initiated last month and Viking Therapeutics is due to publish data from it in the first half of next year.
Viking Therapeutics CEO Brian Lian said: “The high level of interest in this trial allowed us to not only enrol the study more rapidly than anticipated but to significantly exceed our original enrolment target.
“This speaks both to the continued unmet needs of patients with obesity, and the promise demonstrated by the encouraging Phase I study data from VK2735 reported earlier this year.”
Viking Therapeutics previously reported positive data from a Phase I single ascending dose (SAD) and multiple ascending dose (MAD) trial of VK2735 in healthy subjects with a body mass index (BMI) of 30 or higher.
VK2735 showed encouraging safety and tolerability with an expected pharmacokinetic profile in the SAD portion.
In the MAD section, the treatment was found to be well-tolerated with encouraging clinical activity.
Based in California, Viking Therapeutics focuses on developing novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders.