The company claims that in pre-clinical trials the therapy, dubbed ARO-INHBE, reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies. Credit: Shutterstock / Tom Wang

California company Arrowhead Pharmaceuticals has announced that it has dosed the first patient as part of its new Phase I/IIa trial of ARO-INHBE, investigational RNA interference (RNAi) therapeutic designed to tackle obesity by targeting pathways that signal to the body to store fat.

The company claims that in pre-clinical trials the therapy, dubbed ARO-INHBE, reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies.

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ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. Arrowhead hopes to show that a lower level of INHBE variants in humans is associated improved fat distribution and lower risk of metabolic diseases, such as type 2 diabetes.

James Hamilton, chief of discovery and translational medicine at Arrowhead, said: “ARO-INHBE is an important program for Arrowhead that complements our strategic focus on developing and commercializing important RNAi-based therapies for cardiometabolic diseases.

“Further, our preclinical studies have yielded promising results for this novel mechanism to reduce body weight and potentially preserve lean muscle mass resulting in improved body composition. The Phase 1/2 study will evaluate ARO-INHBE as a monotherapy in part 1 and as a combination therapy with tirzepatide in part 2, with both parts enrolling patients with obesity.”

The trial, dubbed the AROINHBE-1001 (NCT06700538) is a dose-escalating study enrolling up to 78 adult volunteers with obesity. The first part of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy. The second part of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist.

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The world of weight loss treatments has heated up significantly over the past few years since the meteoric rise of Novo Nordsk’s GLP1 inhibitor, Wegovy. However, elsewhere in the market Novo has seen some trials fail to meet expectations when a trial of its weight loss drug CagriSegma failed to meet expectations. Meanwhile, Eli Lilly has scored a win in its ongoing competition with Novo Nordisk after a Phase III study showed trial participants experienced 47% more relative weight loss using the former’s weight loss therapy Zepbound (tirzepatide) compared to Novo’s Wegovy (semaglutide).