The trial will recruit up to 90 adult subjects to explore the tolerability, safety, pharmacokinetics, and pharmacodynamics of ARO-ALK7. Credit: Elena Babanova / Shutterstock.

Arrowhead Pharmaceuticals has submitted an application to the New Zealand Medicines and Medical Devices Safety Authority seeking clearance to commence a Phase I/IIa trial of its investigational RNA interference (RNAi) therapy, ARO-ALK7, aimed at treating obesity.

ARO-ALK7 is the first RNAi therapy targeting adipose tissues and is engineered to suppress the activin A receptor type 1C (ACVR1C) gene in fat cells, thereby reducing Activin receptor-like kinase 7 (ALK7) production.

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Arrowhead’s application to start the AROALK7-1001 trial will be reviewed by the Standing Committee on Therapeutic Trials.

Upon approval, the trial will recruit up to 90 adult subjects with obesity to explore the tolerability, safety, pharmacokinetics, and pharmacodynamics of ARO-ALK7.

Part I of the trial will evaluate single and multiple doses of ARO-ALK7 as a standalone therapy while Part II will assess it in combination with tirzepatide.

The company’s Targeted RNAi Molecule (TRiM) platform has facilitated the development of ARO-ALK7.

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Arrowhead Pharmaceuticals discovery and translational medicine chief James Hamilton said: “Arrowhead now has two clinical-stage RNAi-based candidates, ARO-ALK7 and ARO-INHBE, for the treatment of obesity.

“Both have a novel mechanism of action, with ARO-INHBE inhibiting a ligand and ARO-ALK7 inhibiting a receptor to intervene in a known pathway that signals the body to store fat in adipose tissue. Both targets are also supported by human genetics, where loss-of-function carriers have favourable body composition and metabolic characteristics compared to non-carriers.

“The upcoming Phase I/IIa clinical studies will evaluate single and multiple ascending doses as a monotherapy in obese patients, as well as multiple doses in obese patients with or without type 2 diabetes in combination with incretin therapy.”

In September, the company sought approval to conduct a Phase I/IIa trial in New Zealand for another obesity treatment, ARO-INHBE.