The trial will enrol nearly 280 adult subjects with obesity. Credit: Hunterframe / Shutterstock.

Viking Therapeutics has announced the start of a Phase II clinical trial for VK2735, an oral tablet aimed at treating metabolic disorders, such as obesity.

The VENTURE-Oral Dosing Trial is a randomised, double-blind, placebo-controlled multi-centre study that will assess the drug’s safety, tolerability and efficacy in weight loss over 13 weeks.

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Approximately 280 adults who are overweight or obese, with related co-morbid conditions, will be enrolled. They will be randomised to receive either VK2735 or a placebo once daily.

Viking previously reported positive results from a Phase I trial of VK2735, with subjects showing significant weight loss.

The company anticipates that extended treatment could lead to further weight reduction. The safety profile of VK2735 was also favourable, with the majority of side effects being mild.

Viking is also developing a subcutaneous version of VK2735. The subcutaneous formulation has already shown positive results in a Phase II trial, with significant weight loss observed.

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The company plans to commence Phase III development for this formulation in the first half of 2025.

Viking Therapeutics CEO Brian Lian said: “The VENTURE-Oral Phase 2 study represents an important milestone for the VK2735 program, as we advance two formulations of this compound into later-stage development.

“We believe VK2735’s clinical results to date suggest a differentiated profile, with the potential to provide patients and clinicians the option of two well-tolerated formulations, administered by either subcutaneous injection or as a tablet, that each utilise the same active pharmaceutical ingredient.

“This may reduce the potential risk of unexpected side effects and provide flexibility for use in either the induction of weight loss or for the prevention of weight gain, as in a maintenance setting.”