Invetech Lab has moved forward with a Phase 1 obesity clinical trial in Australia for IVL3021, a long-acting injectable formulation of semaglutide. In a regulatory filing on the 28th, the company announced that it had completed the submission of an application for approval of the Phase 1 trial plan for IVL3021 to the Australian Human Research Ethics Committee (HREC). The target indication for this trial is obesity, and it is planned to enroll 40 healthy overweight adults.

■ Comparative evaluation against Wegovy... designed with two cohorts

The key focus of the trial is a comparative evaluation against Wegovy. It will be conducted as an open-label, single ascending dose trial, in which IVL3021 is administered subcutaneously and then compared with Wegovy to evaluate safety, tolerability, pharmacokinetics, and exploratory pharmacodynamic effects.

The trial will be conducted in two separate cohorts. In Cohort 1, IVL3021 will be administered subcutaneously in a single ascending dose sequence, while in Cohort 2, Wegovy will be administered as a single subcutaneous dose to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics.

■ To run for approximately 12 months in Australia... conducted by Nucleus Network

The trial will be conducted in Australia by Nucleus Network. The trial period is scheduled to last approximately 12 months from the date of trial plan approval.

■ "Statistically about a 10% chance of final approval"

Regarding the application for approval of this clinical trial plan, Invetech Lab explained that the statistical probability of the investigational drug ultimately receiving final approval as a medicine is known to be around 10%. It also stated that the clinical trial and product approval process may yield results that fall short of expectations, and that it may therefore change or abandon its commercialization plans.

The company plans to use the contents of this disclosure in future press releases and investor relations (IR) materials.