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.
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.
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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.
Secondary 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.
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