Arrowhead Pharmaceuticals has dosed the first participant in the Phase I/IIa AROALK7-1001 trial of ARO-ALK7, an investigational RNA interference (RNAi) therapeutic aimed at treating obesity.
The trial will initially involve healthy obese people receiving single and multiple escalating doses of ARO-ALK7 as a single agent.
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It is set to advance swiftly to investigate the effects of the therapy in combination with tirzepatide in obese subjects with and without type 2 diabetes (T2D).
The first-in-human, dose-escalating trial will assess the tolerability, pharmacokinetics, pharmacodynamics and safety of the therapy in up to 90 adult volunteers with obesity.
Part 1 of the trial will focus on evaluating the monotherapy, while Part 2 will explore the combo therapy with tirzepatide.
The subcutaneously administered glucagon-like peptide 1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist tirzepatide has been approved in the US and EU for managing T2D since 2022 and weight since 2023/24, respectively.
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By GlobalDataARO-ALK7 is engineered to target a specific pathway that signals the body to store fat in adipose tissue.
According to the company, the therapy operates by silencing the adipocyte expression of the activin A receptor type 1C (ACVR1C) gene, thereby minimising the production of Activin receptor-like kinase 7 (ALK7).
Arrowhead Pharmaceuticals research and development head and chief medical officer James Hamilton said: “Arrowhead’s two clinical-stage RNAi-based obesity programmes, ARO-ALK7 and ARO-INHBE, intervene in a known pathway that signals the body to store fat in adipose tissue.
“Both programmes have strong genetic validation and promising results in preclinical studies, which suggest that silencing the respective genes may lead to reduced body weight and potentially preserve lean muscle mass, resulting in improved body composition.”
This announcement comes after the company reported last December that it had dosed the first subject in a Phase I/IIa trial for ARO-INHBE, the RNAi therapeutic targeting obesity by focusing on fat storage pathways.
