Viking Therapeutics has concluded participant enrolment in its Phase III VANQUISH-1 trial of subcutaneous VK2735, which is being developed to potentially treat metabolic disorders such as obesity.
The company is developing the dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors, in oral and subcutaneous formulations.
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VANQUISH-1 is evaluating VK2735’s safety and efficacy in adults with obesity or who are overweight with related conditions, aiming to advance metabolic disorder-related treatments.
The double-blind, randomised, multicentre, placebo-controlled VANQUISH-1 trial enrolled about 4,650 participants with a body mass index of equal to or greater than 30kg/m² or equal to or greater than 27kg/m², plus at least one weight-related comorbidity.
Participants received weekly subcutaneous injections of VK2735 at 7.5mg, 12.5mg, and 17.5mg doses and placebo, over a period of 78 weeks.
The primary endpoint of the ongoing study focuses on the percentage change in body weight from baseline versus placebo.
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By GlobalDataSecondary endpoints are assessing efficacy and safety measures, including proportions of participants achieving weight reductions of ≥5%, ≥10%, ≥15%, and ≥20%.
The trial includes an extension for 52 weeks, allowing continued treatment after the primary dosing period.
Viking CEO Brian Lian said: “We are excited to announce completion of enrolment in VANQUISH-1 ahead of schedule. As with prior VK2735 studies, the trial accrued rapidly and exceeded our enrolment target.”
Viking is also carrying out the Phase III VANQUISH-2 trial, which is investigating subcutaneous VK2735 in individuals with type 2 diabetes who are overweight or obese. The completion of participant enrolment is anticipated by the first quarter of 2026.
In January 2025, Viking Therapeutics announced the start of a Phase II clinical trial for VK2735 to treat metabolic disorders such as obesity.