Viking plans to meet with the US Food and Drug Administration (FDA) to plan the next steps in the VK2735 development programme. Image Credit: caimacanul / Shutterstock.

Viking Therapeutics has released topline results from the Phase II trial of its dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor, VK2735. The study met its primary and all secondary endpoints.

Ever since Novo Nordisk started reporting the record profits generated by its obesity portfolio, multiple companies have invested in developing new therapies. GlobalData expects the obesity drugs market to generate $37.1bn by 2031. 

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Following the news, Viking’s stock was up by 121% at market close on 27 February, compared to market close on 26 February. Viking’s market cap stands at $8.5bn. Viking plans to meet with the US Food and Drug Administration (FDA) to discuss the next steps for the VK2735 development programme.

The placebo-controlled Phase II VENTURE trial (NCT06068946) evaluated the safety and efficacy of VK2735 over 13 weeks in adults who are either obese with a body mass index (BMI) of 30kg/m² or are overweight with a BMI of 27kg/m² with at least one weight-related comorbidity. The study achieved its primary endpoint by demonstrating a 13.1% reduction in mean body weight from baseline at 13 weeks, compared to placebo.

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The reduction in weight loss was progressive over 13 weeks. Furthermore, no plateau for weight loss was observed during the treatment period. The study achieved its secondary endpoint with up to 88% of patients in the treatment group achieving 10% or more weight loss, compared to 4% of the population achieving the same result in the placebo group.

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A total of 23 of the 174 participants enrolled in the trial discontinued treatment. Five of these were in the placebo cohort and the remaining 18 were in the treatment cohorts. Commonly observed treatment observed adverse effects included nausea and vomiting, both mild to moderate in severity.

Viking is also evaluating the oral formulation of VK2735 in a Phase I trial (NCT05203237). The study is expected to enrol 136 participants with increased BMI who are otherwise healthy.

In May 2023, Novo Nordisk reported positive results from the OASIS 1 Phase IIIa clinical trial (NCT05035095) of oral formulation of its blockbuster obesity drug Wegovy (semaglutide). The study observed that 84.9% of the semaglutide arm achieved a weight loss of 5% or more, compared to 25.8% of participants achieving the same result in the placebo group.